| Ethiqa XR ® (buprenorphine extended-release injectable suspension) | Product name | Fidelis Animal Health, Inc. | 2026-10-06 |
| These highlights do not include all the information needed to use REXTOVY™ Nasal Spray safely and effectively. See full prescribing information for REXTOVY™ Nasal Spray. REXTOVY™ (naloxone hydrochloride) Nasal Spray Initial U.S. Approval: 1971 | Product name | International Medication Systems, Ltd. | 2026-09-30 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration, CIII Initial U.S. Approval: 1981 | Product name | REMEDYREPACK INC. | 2026-09-17 |
| Naloxone Hydrochloride Nasal Spray | Product name | Amneal Pharmaceuticals LLC | 2026-08-25 |
| NARCAN® Naloxone HCl Nasal Spray 4 mg Drug Facts | Product name | Emergent Devices Inc. | 2026-08-17 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-08-17 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-08-17 |
| These highlights do not include all the information needed to use SUBLOCADE ® safely and effectively. See full prescribing information for SUBLOCADE. SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use, CIII Initial U.S. Approval: 2002 | Product name | Indivior Inc. | SGS North America Inc. | Eurofins Lancaster Laboratories, LLC | Curia New Mexico, LLC | Curia New Mexico, LLC. | Curia Global, Inc. | Sharp Packaging Services, LLC | Nelson Laboratories, LLC | Indivior UK Limited | Wickham Micro Limited | QUOTIENT SCIENCES (ALNWICK) LIMITED | Sterling Pharma Solutions Limited | 2026-07-27 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 2026-07-26 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | REMEDYREPACK INC. | 2026-07-17 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration, CIII Initial U.S. Approval: 1981 | Product name | Advagen Pharma Ltd | Rubicon Research Limited | 2026-07-17 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE Sublingual Tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-07-07 |
| Naloxone Hydrochloride Injection, USP | Product name | Civica, Inc. | 2026-06-30 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Bryant Ranch Prepack | 2026-06-29 |
| Pentazocine and Naloxone Tablets , USP CIV | Product name | Actavis Pharma, Inc. | 2026-06-19 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-18 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-16 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-16 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Bryant Ranch Prepack | 2026-06-16 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | Major Pharmaceuticals | 2026-06-16 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-12 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-11 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS . BUPRENORPHINE AND NALOXONE sublingual tablets, for sublingual administration, CIII Initial U.S. Approval: 2002 | Product name | SpecGx LLC | 2026-06-10 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-06-10 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-06-09 |
| These highlights do not include all the information needed to use B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-08 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration, CIII Initial U.S. Approval: 1981 | Product name | SpecGx LLC | 2026-06-05 |
| Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only | Product name | A-S Medication Solutions | 2026-06-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-06-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Bryant Ranch Prepack | 2026-06-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. Buprenorphine Transdermal System, CIII Initial U.S. Approval: 1981 | Product name | Rhodes Pharmaceuticals LLC | LTS Lohmann Therapy Systems Corp. | LTS Lohmann Therapie-Systeme AG | 2026-05-29 |
| NALOXONE HYDROCHLORIDE | Product name | Hospira, Inc. | 2026-05-27 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. Buprenorphine Transdermal System, CIII Initial U.S. Approval: 1981 | Product name | Rhodes Pharmaceuticals LLC | LTS Lohmann Therapy Systems Corp. | LTS Lohmann Therapie-Systeme AG | 2026-05-26 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE s ublingual t ablets, CIII Initial U.S. Approval: 1981 | Product name | Actavis Pharma, Inc. | 2026-05-25 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-05-22 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS . BUPRENORPHINE AND NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-05-14 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-05-14 |
| Meitheal Pharmaceuticals Inc. | Sterinova Inc. human prescription drug label | Product name | Meitheal Pharmaceuticals Inc. | Sterinova Inc. | 2026-05-13 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-05-13 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE transdermal system, CIII Initial U.S. Approval: 1981 | Product name | Teva Pharmaceuticals USA, Inc. | 2026-05-12 |
| Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only | Product name | Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited | 2026-05-05 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Rhodes Pharmaceuticals LLC | Knoa Pharmaceuticals LLC | 2026-05-04 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Rhodes Pharmaceuticals LLC | Knoa Pharmaceuticals LLC | Halo Pharmaceutical Inc. | 2026-05-01 |
| These highlights do not include all the information needed to use BUTRANS ® safely and effectively. See full prescribing information for BUTRANS. BUTRANS ® (buprenorphine) transdermal system, CIII Initial U.S. Approval: 1981 | Product name | Knoa Pharma LLC | Lohman Therapie System | 2026-05-01 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE transdermal system, CIII Initial U.S. Approval: 1981 | Product name | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc. | 2026-04-28 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE transdermal system, CIII Initial U.S. Approval: 1981 | Product name | Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | 2026-04-28 |
| BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Golden State Medical Supply, Inc. | 2026-04-24 |
| NARCAN® Naloxone HCl Nasal Spray 4 mg Drug Facts | Product name | Sportpharm LLC | 2026-04-24 |
| NARCAN® Naloxone HCl Nasal Spray 4 mg Drug Facts | Product name | Emergent Devices Inc. | 2026-04-22 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII Initial U.S. Approval: 2002 | Product name | Redpharm Drug | 2026-04-22 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS . BUPRENORPHINE AND NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Unit Dose Solutions, Inc. | 2026-04-16 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-04-16 |
| These highlights do not include all the information needed to use BUTRANS ® safely and effectively. See full prescribing information for BUTRANS. BUTRANS ® (buprenorphine) transdermal system, CIII Initial U.S. Approval: 1981 | Product name | Knoa Pharma LLC | Lohman Therapie System | 2026-04-14 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-04-08 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII Initial U.S. Approval: 2002 | Product name | Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | 2026-04-07 |
| These highlights do not include all the information needed to use B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-04-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-04-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Bryant Ranch Prepack | 2026-04-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Bryant Ranch Prepack | 2026-04-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Bryant Ranch Prepack | 2026-04-03 |
| Naloxone HCl Nasal Spray Drug Facts | Product name | BluePoint Laboratories | Padagis Israel Pharmaceuticals Ltd | 2026-04-02 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | REMEDYREPACK INC. | 2026-03-25 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII Initial U.S. Approval: 2002 | Product name | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems, Inc | 2026-03-23 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | REMEDYREPACK INC. | 2026-03-23 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE transdermal system, CIII Initial U.S. Approval: 1981 | Product name | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc. | 2026-03-23 |
| HF Acquisition Co. LLC. DBA HealthFirst human prescription drug label | Product name | HF Acquisition Co. LLC. DBA HealthFirst | 2026-03-19 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Clinical Solutions Wholesale, LLC | 2026-03-06 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Clinical Solutions Wholesale, LLC | 2026-03-05 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Major Pharmaceuticals | 2026-03-03 |
| These highlights do not include all the information needed to use REZENOPY nasal spray safely and effectively. See full prescribing information for REZENOPY nasal spray. REZENOPY™ (naloxone HCl) nasal spray, 10 mg Initial U.S. Approval:1971 | Product name | Scienture LLC | Summit Biosciences Inc. | 2026-03-03 |
| These highlights do not include all the information needed to use REZENOPY nasal spray safely and effectively. See full prescribing information for REZENOPY nasal spray. REZENOPY™ (naloxone HCl) nasal spray, 10 mg Initial U.S. Approval:1971 | Product name | Scienture LLC | Summit Biosciences Inc. | 2026-03-03 |
| NALOXONE HYDROCHLORIDE INJECTION, USP Opioid Antagonist Rx Only | Product name | Henry Schein, Inc | 2026-03-02 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | Major Pharmaceuticals | 2026-03-02 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE Sublingual Tablets for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | PAI Holdings, LLC dba PAI Pharma | 2026-02-28 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE Sublingual Tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | PAI Holdings, LLC dba PAI Pharma | 2026-02-28 |
| These highlights do not include all the information needed to use BUBRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use CIII Initial U.S. Approval: 2002 | Product name | Redpharm Drug | 2026-02-21 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE Sublingual Tablets for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | Ethypharm USA Corp. | 2026-02-19 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Unit Dose Solutions, Inc. | 2026-02-19 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE Sublingual Tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | Ethypharm Inc | 2026-02-19 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE sublingual tablets, USP safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE sublingual tablets, USP. BUPRENORPHINE and NALOXONE sublingual tablets, USP, CIII Initial U.S. Approval: 2002 | Product name | Rhodes Pharmaceuticals L.P. | Purdue Pharmaceuticals L.P. | Halo Pharmaceutical Inc. | 2026-02-17 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Rhodes Pharmaceuticals L.P. | Purdue Pharmaceuticals L.P. | 2026-02-17 |
| These highlights do not include all the information needed to use REZENOPY nasal spray safely and effectively. See full prescribing information for REZENOPY nasal spray. REZENOPY™ (naloxone HCl) nasal spray, 10 mg Initial U.S. Approval:1971 | Product name | Scienture LLC | Summit Biosciences Inc. | 2026-02-13 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2026-02-11 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE Sublingual Tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | REMEDYREPACK INC. | 2026-02-11 |
| REMEDYREPACK INC. human prescription drug label | Product name | REMEDYREPACK INC. | 2026-02-10 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2026-02-10 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | REMEDYREPACK INC. | 2026-02-10 |
| Naloxone Hydrochloride Injection, USP Opioid Antagonist Rx only | Product name | Lifestar Pharma LLC | Mankind Pharma Limited | 2026-02-09 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE s ublingual t ablets, CIII Initial U.S. Approval: 2002 | Product name | Actavis Pharma, Inc. | 2026-02-06 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | A-S Medication Solutions | 2026-02-06 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | REMEDYREPACK INC. | 2026-02-03 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. Buprenorphine Transdermal System, CIII Initial U.S. Approval: 1981 | Product name | Rhodes Pharmaceuticals L.P. | LTS Lohmann Therapy Systems Corp. | LTS Lohmann Therapie-Systeme AG | 2026-02-03 |
| These highlights do not include all the information needed to use B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Amneal Pharmaceuticals LLC | 2026-02-02 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII Initial U.S. Approval: 2002 | Product name | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 2026-01-30 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | REMEDYREPACK INC. | 2026-01-29 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Lannett Company, Inc. | 2026-01-28 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 2026-01-28 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 2026-01-24 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Redpharm Drug | 2026-01-23 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 2026-01-23 |
| These highlights do not include all the information needed to use BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE and NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | Major Pharmaceuticals | 2026-01-23 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 2026-01-23 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration, CIII Initial U.S. Approval: 1981 | Product name | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 2026-01-23 |
| These highlights do not include all the information needed to use BUBRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use CIII Initial U.S. Approval: 2002 | Product name | Mylan Pharmaceuticals Inc. | 2026-01-15 |
| Naloxone Hydrochloride Nasal Spray | Product name | AvKARE | 2026-01-14 |
| RiVive ® Naloxone HCl Nasal Spray 3 mg Emergency Treatment of Opioid Overdose | Product name | Harm Reduction Therapeutics, Inc. | 2026-01-13 |
| Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only | Product name | Sina Health Inc | 2026-01-12 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use CIII Initial U.S. Approval: 2002 | Product name | Dr.Reddys Laboratories Inc | LTS Lohmann Therapy Systems Corp. | Pharmaron Manufacturing services (UK) LTD | 2026-01-12 |
| These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use CIII Initial U.S. Approval: 2002 | Product name | Dr.Reddys Laboratories Inc | LTS Lohmann Therapy Systems Corp. | Pharmaron Manufacturing services (UK) LTD | 2026-01-12 |
| These highlights do not include all the information needed to use B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002 | Product name | Amneal Pharmaceuticals LLC | 2026-01-09 |
| These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE transdermal system, CIII Initial U.S. Approval: 1981 | Product name | Amneal Pharmaceuticals NY LLC | 2026-01-09 |
| Buprenorphine and Naloxone Sublingual Tablets CIII Rx Only These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Product name | AvPAK | 2026-01-08 |
| Buprenorphine Tablet CIII Rx only These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. Initial U.S. Approval: 1981 | Product name | AvPAK | 2026-01-08 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film. SUBOXONE (buprenorphine and naloxone) sublingual film, for sublingual or buccal use, CIII Initial U.S. Approval: 2002 | Product name | INDIVIOR INC. | SGS North America Inc. | Aquestive Therapeutics | Alcami Carolinas Corporation | Infinity Labs IN, Inc | Sharp Packaging Services, LLC | SpecGx LLC | Macfarlan Smith Limited | INDIVIOR UK Limited | Butterworth Laboratories Ltd | QUOTIENT SCIENCES (ALNWICK) LIMITED | Siegfried AG | Veranova, L.P. | PPD Development, L.P. | 2026-01-08 |
| These highlights do not include all the information needed to use SUBLOCADE ® safely and effectively. See full prescribing information for SUBLOCADE. SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use, CIII Initial U.S. Approval: 2002 | Product name | Indivior Inc. | SGS North America Inc. | Eurofins Lancaster Laboratories, LLC | Curia New Mexico, LLC | Curia New Mexico, LLC. | Curia Global, Inc. | Sharp Packaging Services, LLC | Nelson Laboratories, LLC | Indivior UK Limited | Wickham Micro Limited | QUOTIENT SCIENCES (ALNWICK) LIMITED | Sterling Pharma Solutions Limited | Curia Massachusetts, Inc. | 2026-01-08 |
| Naloxone HCl Nasal Spray Drug Facts | Product name | Padagis Israel Pharmaceuticals Ltd | 2026-01-06 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, CIII Initial U.S. Approval: 1981 | Product name | Advagen Pharma Ltd | Rubicon Research Limited | 2026-01-05 |
| These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981 | Product name | Major Pharmaceuticals | 2026-01-05 |
| These highlights do not include all the information needed to use BELBUCA safely and effectively. See full prescribing information for BELBUCA. BELBUCA ® (buprenorphine buccal film), CIII Initial U.S. Approval: 1981 | Product name | BioDelivery Sciences International Inc | 2026-01-02 |