| 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 | Rhodes Pharmaceuticals LLC | LTS Lohmann Therapy Systems Corp. | LTS Lohmann Therapie-Systeme AG | 20260529 | 17 |
| 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 | REMEDYREPACK INC. | 20260522 | 8 |
| 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 | Bryant Ranch Prepack | 20260514 | 107 |
| 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 | Bryant Ranch Prepack | 20260514 | 106 |
| 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 | Bryant Ranch Prepack | 20260513 | 6 |
| 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 | Rhodes Pharmaceuticals LLC | Knoa Pharmaceuticals LLC | 20260504 | 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 | Rhodes Pharmaceuticals LLC | Knoa Pharmaceuticals LLC | Halo Pharmaceutical Inc. | 20260501 | 9 |
| 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 | Knoa Pharma LLC | Lohman Therapie System | 20260501 | 32 |
| 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 | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc. | 20260428 | 4 |
| 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 | Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | 20260428 | 3 |
| 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 | Golden State Medical Supply, Inc. | 20260424 | 2 |
| 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 | Redpharm Drug | 20260422 | 1 |
| 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 | Unit Dose Solutions, Inc. | 20260416 | 1 |
| 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 | Bryant Ranch Prepack | 20260416 | 2 |
| 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 | Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | 20260407 | 2 |
| 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 | Bryant Ranch Prepack | 20260403 | 1007 |
| 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 | Bryant Ranch Prepack | 20260403 | 104 |
| 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 | Bryant Ranch Prepack | 20260403 | 102 |
| 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 | Bryant Ranch Prepack | 20260403 | 107 |
| 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 | Bryant Ranch Prepack | 20260403 | 104 |
| 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 | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems, Inc | 20260323 | 6 |
| 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 | Clinical Solutions Wholesale, LLC | 20260306 | 2 |
| 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 | Clinical Solutions Wholesale, LLC | 20260305 | 1 |
| 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 | Major Pharmaceuticals | 20260303 | 9 |
| 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 | Major Pharmaceuticals | 20260302 | 9 |
| 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 | Redpharm Drug | 20260221 | 4 |
| 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 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | Ethypharm USA Corp. | 20260219 | 7 |
| 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 | Unit Dose Solutions, Inc. | 20260219 | 1 |
| 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 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | Ethypharm Inc | 20260219 | 6 |
| 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 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 20260211 | 32 |
| 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 | REMEDYREPACK INC. | 20260211 | 1 |
| 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 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 20260210 | 33 |
| 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 | REMEDYREPACK INC. | 20260210 | 1 |
| 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 | Actavis Pharma, Inc. | 20260206 | 49 |
| 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 | A-S Medication Solutions | 20260206 | 5 |
| 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 | REMEDYREPACK INC. | 20260203 | 15 |
| 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 | Amneal Pharmaceuticals LLC | 20260202 | 55 |
| 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 | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 20260130 | 1 |
| 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 | REMEDYREPACK INC. | 20260129 | 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, CIII Initial U.S. Approval: 2002 | Lannett Company, Inc. | 20260128 | 32 |
| 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 | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 20260128 | 1 |
| 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 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20260124 | 32 |
| 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 | Redpharm Drug | 20260123 | 2 |
| 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 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20260123 | 31 |
| 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 | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 20260123 | 1 |
| 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 | Mylan Pharmaceuticals Inc. | 20260115 | 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 | Dr.Reddys Laboratories Inc | LTS Lohmann Therapy Systems Corp. | Pharmaron Manufacturing services (UK) LTD | 20260112 | 10 |
| 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 | Dr.Reddys Laboratories Inc | LTS Lohmann Therapy Systems Corp. | Pharmaron Manufacturing services (UK) LTD | 20260112 | 11 |
| 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 | Amneal Pharmaceuticals NY LLC | 20260109 | 19 |
| 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 | AvPAK | 20260108 | 11 |
| 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 | AvPAK | 20260108 | 2 |
| 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 | Advagen Pharma Ltd | Rubicon Research Limited | 20260105 | 6 |
| 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 | BioDelivery Sciences International Inc | 20260102 | 18 |
| 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 | Alvogen Inc. | 20260101 | 19 |
| Buprenorphine Hydrochloride Injection, for intravenous or intramuscular administration | Hospira, Inc. | Macfarlan Smith Limited | 20251231 | 20 |
| These highlights do not include all the information needed to use BRIXADI safely and effectively. See full prescribing information for BRIXADI. BRIXADI ® (buprenorphine) extended-release injection for subcutaneous use CIII Initial U.S. Approval: 2002 | Braeburn Inc. | 20251231 | 6 |
| 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 | Redpharm Drug | 20251227 | 4 |
| These highlights do not include all the information needed to use ZUBSOLV ® safely and effectively. See full prescribing information for ZUBSOLV. ZUBSOLV (buprenorphine and naloxone sublingual tablets), CIII Initial U.S. Approval: 2002 | Orexo US, Inc. | 20251227 | 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, CIII Initial U.S. Approval: 2002 | SpecGx LLC | 20251224 | 33 |
| 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 | Redpharm Drug | 20251223 | 4 |
| 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 | Indivior Inc. | Curia Massachusetts, Inc. | QUOTIENT SCIENCES (ALNWICK) LIMITED | Indivior UK Limited | Curia New Mexico, LLC. | Sharp Packaging Services, LLC | Sterling Pharma Solutions Limited | Wickham Micro Limited | Curia Global, Inc. | Curia New Mexico, LLC | Eurofins Lancaster Laboratories, LLC | Nelson Laboratories, LLC | SGS North America Inc. | 20251222 | 42 |
| 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 | INDIVIOR INC. | Alcami Carolinas Corporation | Aquestive Therapeutics | Butterworth Laboratories Ltd | INDIVIOR UK Limited | Infinity Labs IN, Inc | Macfarlan Smith Limited | PPD Development, L.P. | QUOTIENT SCIENCES (ALNWICK) LIMITED | SGS North America Inc. | Sharp Packaging Services, LLC | Siegfried AG | SpecGx LLC | Veranova, L.P. | 20251222 | 37 |
| Buprenorphine Hydrochloride Injection | Par Health USA, LLC | 20251218 | 22 |
| 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 | Actavis Pharma, Inc. | 20251216 | 34 |
| 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 | Redpharm Drug | 20251211 | 3 |
| 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 | SpecGx LLC | 20251211 | 2 |
| 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 | Redpharm Drug | 20251202 | 2 |
| 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 | REMEDYREPACK INC. | 20251027 | 3 |
| 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 | Bryant Ranch Prepack | 20251023 | 100 |
| 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 | REMEDYREPACK INC. | 20250924 | 7 |
| 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 | Alvogen Inc. | 20250912 | 4 |
| 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 | Bryant Ranch Prepack | 20250729 | 7 |
| 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 | Bryant Ranch Prepack | 20250729 | 111 |
| 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 | A-S Medication Solutions | 20250528 | 1 |
| 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 | Bryant Ranch Prepack | 20250328 | 7 |
| Buprenorphine Hydrochloride Injection CIII for intravenous or intramuscular administration | Hikma Pharmaceuticals USA Inc. | 20250313 | 8 |
| 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 | Clinical Solutions Wholesale, LLC | 20250217 | 1 |
| CIII Buprenorphine Hydrochloride injection, for intravenous or intramuscular administration, CIII | Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited | 20250211 | 3 |
| 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 | Clinical Solutions Wholesale, LLC | 20250203 | 1 |
| 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 | American Health Packaging | 20241230 | 5 |
| a1c1f498-e101-467f-b81c-1451c44e7a01 | PAYLESS COMPOUNDERS, LLC | 20241211 | 10 |
| Buprenorphine Sublingual C-III | Direct_Rx | 20241016 | 2 |
| Buprenorphine Sublingual C-III | Direct_Rx | 20241015 | 1 |
| Buprenorphine Sublingual C-lll | Direct_rx | 20240913 | 1 |
| 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 | American Health Packaging | 20240820 | 5 |
| 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 | Bryant Ranch Prepack | 20240820 | 104 |
| 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 | Bryant Ranch Prepack | 20240814 | 105 |
| 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 | RedPharm Drug, Inc. | 20240808 | 2 |
| 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 | RedPharm Drug | 20240725 | 1 |
| 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 | Redpharm drug | 20240718 | 2 |
| 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 | Redpharm drug | 20240718 | 2 |
| 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 | Teva Pharmaceuticals USA, Inc. | 20240531 | 20 |
| 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 | Bryant Ranch Prepack | 20240520 | 7 |
| 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 | Bryant Ranch Prepack | 20240520 | 103 |
| 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 | Bryant Ranch Prepack | 20240517 | 5 |
| 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 | Bryant Ranch Prepack | 20240112 | 102 |
| 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 | Clinical Solutions Wholesale, LLC | 20240109 | 2 |
| 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 | Clinical Solutions Wholesale, LLC | 20240109 | 2 |
| 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 | Clinical Solutions Wholesale, LLC | 20240109 | 2 |
| 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 | Clinical Solutions Wholesale, LLC | 20240108 | 4 |
| 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 | Bryant Ranch Prepack | 20231116 | 104 |
| 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 | NuCare Pharmaceuticals,Inc. | 20230717 | 2 |
| 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 | Accord Healthcare, Inc | WES PHARMA INC | 20230503 | 8 |
| 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 | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 20230127 | 1 |
| 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 | NuCare Pharmaceuticals,Inc. | 20230117 | 2 |
| 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 | Clinical Solutions Wholesale, LLC | 20190712 | 2 |
| 1170 BUPRENORPHINE SL 8MG | H.J. Harkins Company, Inc. | 20181009 | 1 |
| 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 | Aidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals | 20180531 | 4 |
| These highlights do not include all the information needed to use BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS. BUPRENORPHINE HYDROCHLORIDE sublingual tablets, for sublingual administration CIII 996 997 Initial U.S. Approval: 2002 | Contract Pharmacy Services-PA | Coupler Enterprises | 20170915 | 1 |
| 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. 990 991 BUPRENORPHINE Sublingual Tablets, for sublingual administration CIII Initial U.S. Approval: 2002 | Contract Pharmacy Services-PA | Coupler Enterprises | 20170915 | 1 |
| 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 994 995 Initial U.S. Approval: 2002 | Contract Pharmacy Services-PA | Coupler Enterprises | 20170915 | 1 |
| 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 | Aidarex Pharmaceuticals LLC | 20161206 | 1 |
| 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 | Aidarex Pharmaceuticals LLC | 20161206 | 1 |
| These highlights do not include all the information needed to use Buprenorphine HCl Sublingual Tablets safely and effectively. See full prescribing information for Buprenorphine HCl Sublingual Tablets. BUPRENORPHINE Hydrochloride sublingual tablets for sublingual administration CIII Initial U.S. Approval: 2002 | TYA Pharmaceuticals | 20160314 | 3 |
| These highlights do not include all the information needed to use Buprenorphine HCl Sublingual Tablets safely and effectively. See full prescribing information for Buprenorphine HCl Sublingual Tablets. BUPRENORPHINE Hydrochloride sublingual tablets for sublingual administration CIII Initial U.S. Approval: 2002 | TYA Pharmaceuticals | 20160208 | 4 |
| 7fc0c3fd-5122-43ce-995d-a55a7ea02371 | PAYLESS COMPOUNDERS, LLC | 20151029 | 3 |
| c385095b-152a-45fd-8c49-3e44493e9a00 | PAYLESS COMPOUNDERS, LLC | 20151021 | 2 |
| 8081ccb8-1b38-4673-a9dd-0fb18fa6038a | PAYLESS COMPOUNDERS, LLC | 20151002 | 1 |
| Buprenorphine Hydrochloride Injection | Rebel Distributors Corp | 20101210 | 1 |
| 97677ce7-9562-43d0-8b99-8d1f37c1e3c6 | Physicians Total Care, Inc. | 20100727 | 1 |