| These highlights do not include all the information needed to use TRI-SPRINTEC ® safely and effectively. See full prescribing information for TRI-SPRINTEC ® . TRI-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Product name | Preferred Pharmaceuticals Inc. | 2026-10-12 |
| These highlights do not include all the information needed to use levonorgestrel and ethinyl estradiol tablets safely and effectively. See full prescribing information for levonorgestrel and ethinyl estradiol tablets. LEVONORGESTREL and ETHINYL ESTRADIOL tablets for oral use Initial U.S. Approval: 1982 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-10-07 |
| These highlights do not include all the information needed to use DAYSEE safely and effectively. See full prescribing information for DAYSEE. Daysee TM [levonorgestrel and ethinyl estradiol tablets USP (0.15 mg/0.03 mg) and ethinyl estradiol tablets USP (0.01 mg)] for oral use Initial U.S. Approval: 1982 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-10-01 |
| These highlights do not include all the information needed to use levonorgestrel and ethinyl estradiol tablets safely and effectively. See full prescribing information for levonorgestrel and ethinyl estradiol tablets. LEVONORGESTREL and ETHINYL ESTRADIOL tablets for oral use Initial U.S. Approval: 1982 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-10-01 |
| These highlights do not include all the information needed to use ANNOVERA safely and effectively. See full prescribing information for ANNOVERA ANNOVERA® (segesterone acetate and ethinyl estradiol) vaginal ring Initial U.S. Approval: 2018 | Product name | Mayne Pharma | Sever Pharma Solutions AB | Sharp Packaging Services, LLC | 2026-09-17 |
| ETONOGESTREL and ETHINYL ESTRADIOL vaginal ring, for intravaginal use These highlights do not include all the information needed to use ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING safely and effectively. See full prescribing information for ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING. ETONOGESTREL and ETHINYL ESTRADIOL vaginal ring, for intravaginal use Initial U.S. Approval: 2001 | Product name | AvKARE | 2026-09-09 |
| Cryselle ® (norgestrel and ethinyl estradiol tablets, USP) | Product name | Teva Pharmaceuticals, Inc. | 2026-09-04 |
| These highlights do not include all the information needed to use levonorgestrel and ethinyl estradiol tablets safely and effectively. See full prescribing information for levonorgestrel and ethinyl estradiol tablets. LEVONORGESTREL and ETHINYL ESTRADIOL tablets for oral use Initial U.S. Approval: 1982 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-08-31 |
| These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Product name | Preferred Pharmaceuticals, Inc. | 2026-08-31 |
| These highlights do not include all the information needed to use TYBLUME safely and effectively. See full prescribing information for TYBLUME. TYBLUME (levonorgestrel and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1968 (norgestrel and ethinyl estradiol) | Product name | Exeltis USA, Inc. | Laboratorios Leon Farma S.A. | 2026-08-27 |
| CAMILA ® (NORETHINDRONE TABLETS USP, 0.35 MG) | Product name | Mayne Pharma Inc. | Piramal Healthcare UK Ltd. | 2026-08-24 |
| ERRIN ® (NORETHINDRONE TABLETS USP, 0.35 MG) | Product name | Mayne Pharma Inc. | Piramal Healthcare UK Ltd. | 2026-08-24 |
| Isibloom TM (Desogestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg Rx only | Product name | Bryant Ranch Prepack | 2026-08-12 |
| These highlights do not include all the information needed to use Estarylla™ safely and effectively. See full prescribing information for Estarylla™. Estarylla™ (NORGESTIMATE and ETHINYL ESTRADIOL tablets) for oral use Initial U.S. Approval: 1989 | Product name | Bryant Ranch Prepack | 2026-08-12 |
| These highlights do not include all the information needed to use DAYSEE safely and effectively. See full prescribing information for DAYSEE. Daysee TM [levonorgestrel and ethinyl estradiol tablets USP (0.15 mg/0.03 mg) and ethinyl estradiol tablets USP (0.01 mg)] for oral use Initial U.S. Approval: 1982 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-07-31 |
| These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1989 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-29 |
| ETONOGESTREL and ETHINYL ESTRADIOL VAGINAL RING These highlights do not include all the information needed to use Etonogestrel and ethinyl estradiol vaginal ring safely and effectively. See full prescribing information for Etonogestrel and ethinyl estradiol vaginal ring. Initial U.S. Approval: 2001 | Product name | AvKARE | 2026-07-13 |
| These highlights do not include all the information needed to use TWIRLA ® safely and effectively. See full prescribing information for TWIRLA. TWIRLA (levonorgestrel and ethinyl estradiol) transdermal system Initial U.S. Approval: 1968 (norgestrel and ethinyl estradiol) | Product name | Agile Therapeutics, Inc. | Exeltis USA, Inc. | Corium Innovations, Inc. | 2026-06-30 |
| These highlights do not include all the information needed to use ASHLYNA safely and effectively. See full prescribing information for ASHLYNA. ASHLYNA ® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets), for oral use Initial U.S. Approval: 1982 | Product name | A-S Medication Solutions | 2026-06-23 |
| These highlights do not include all the information needed to use Mono-Linyah safely and effectively. See full prescribing information for Mono-Linyah. Mono-Linyah (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval:1989 | Product name | A-S Medication Solutions | 2026-06-23 |
| These highlights do not include all the information needed to use TWIRLA ® safely and effectively. See full prescribing information for TWIRLA. TWIRLA (levonorgestrel and ethinyl estradiol) transdermal system Initial U.S. Approval: 1968 (norgestrel and ethinyl estradiol) | Product name | Agile Therapeutics, Inc. | Exeltis USA, Inc. | Corium Innovations, Inc. | 2026-06-23 |
| VIORELE | Product name | A-S Medication Solutions | 2026-06-23 |
| These highlights do not include all the information needed to use ESTRADIOL AND NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL AND NORETHINDRONE ACETATE TABLETS. ESTRADIOL and NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 1998 | Product name | Ingenus Pharmaceuticals, LLC | Novast Laboratories, Ltd. | 2026-05-29 |
| Junel ® Fe 28 Day (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay. | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-05-21 |
| Turqoz TM (norgestrel and ethinyl estradiol tablets USP) 0.3 mg/0.03 mg | Product name | A-S Medication Solutions | 2026-05-21 |
| Kurvelo™ (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/30 mcg)Rx only | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-05-20 |
| These highlights do not include all the information needed to use DROSPIRENONE and ETHINYL ESTRADIOL tablets safely and effectively. See full prescribing information for DROSPIRENONE and ETHINYL ESTRADIOL tablets. DROSPIRENONE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 2001 | Product name | Apotex Corp. | Naari Pte.Limited | 2026-05-14 |
| These highlights do not include all the information needed to use DROSPIRENONE and ETHINYL ESTRADIOL tablets safely and effectively. See full prescribing information for DROSPIRENONE and ETHINYL ESTRADIOL tablets. DROSPIRENONE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 2001 | Product name | Apotex Corp. | Naari Pte.Limited | 2026-04-29 |
| NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal system | Product name | Zydus Lifesciences Limited | 2026-04-16 |
| These highlights do not include all the information needed to use NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal system Initial U.S. Approval: 2001 | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2026-04-16 |
| WERA TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.5 mg/0.035 mg | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2026-04-15 |
| DASETTATM 7/7/7 (norethindrone/ethinyl estradiol Tablets, USP) | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2026-04-14 |
| Levonorgestrel and Ethinyl Estradiol Tablets USP Rx only | Product name | Apotex Corp. | Naari Pte Limited | Naari Pharma Private Limited | 2026-04-04 |
| Levonorgestrel and Ethinyl Estradiol Tablets USP 0.15mg/0.03 mg | Product name | Apotex Corp. | Naari Pte Limited | Naari Pharma Private Limited | 2026-04-03 |
| Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/ 0.02 mg Rx only | Product name | A-S Medication Solutions | 2026-03-26 |
| These highlights do not include all the information needed to use VESTURA safely and effectively. See full prescribing information for VESTURA . VESTURA ® (drospirenone and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 2001 | Product name | Teva Pharmaceuticals, Inc. | 2026-03-24 |
| Junel FE | Product name | Direct_Rx | 2026-03-17 |
| These highlights do not include all the information needed to use DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS safely and effectively. See full prescribing information for safely and effectively. See full prescribing information for DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM . DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS, for oral use Initial U.S. Approval: 2010 | Product name | Sandoz Inc | Bayer HealthCare Pharmaceuticals Inc. | 2026-03-04 |
| These highlights do not include all the information needed to use OCELLA safely and effectively. See full prescribing information for OCELLA. OCELLA (drospirenone/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 2001 | Product name | TEVA PHARMACEUTICALS USA, INC. | Bayer HealthCare Pharmaceuticals Inc. | 2026-03-04 |
| These highlights do not include all the information needed to use SAFYRAL safely and effectively. See full prescribing information for SAFYRAL. SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) for oral use Initial U.S. Approval: 2010 | Product name | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | 2026-03-04 |
| Cryselle ® (norgestrel and ethinyl estradiol tablets, USP) | Product name | A-S Medication Solutions | 2026-03-03 |
| These highlights do not include all the information needed to use DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS. DROSPIRENONE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 2001 | Product name | A-S Medication Solutions | 2026-03-03 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | Product name | A-S Medication Solutions | 2026-03-03 |
| VIENVA TM | Product name | A-S Medication Solutions | 2026-03-03 |
| These highlights do not include all the information needed to use BEYAZ safely and effectively. See full prescribing information for BEYAZ. BEYAZ (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), for oral use Initial U.S. Approval: 2010 | Product name | Bayer HealthCare Pharmaceuticals Inc. | Sharp Corporation | Bayer AG | 2026-03-02 |
| Rx only | Product name | Dr. Reddy’s Laboratories Inc. | Novast Laboratories, Ltd. | 2026-02-13 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-02-06 |
| ALYACEN 7/7/7(Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg) ALYACEN 1/35(Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-31 |
| BRIELLYN ® (Norethindrone and Ethinyl Estradiol Tablets, USP) | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-31 |
| Norethindrone Tablets, USP 0.35 mg | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-31 |
| These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES. NORETHINDRONE ACETATE and ETHINYL ESTRADIOL capsules and FERROUS FUMARATE capsules, for oral use Initial U.S. Approval: 1968 | Product name | Glenmark Pharmaceuticals Inc., USA | Cyndea Pharma SL | 2026-01-31 |
| VIORELE ® (Desogestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.02 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) Rx only | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-31 |
| Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.09 mg/0.02 mg | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-30 |
| These highlights do not include all the information needed to use HAILEY 24 FE safely and effectively. See Full Prescribing Information for HAILEY 24 FE. HAILEY ® 24 FE (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets), for oral use Initial U.S. Approval: 1968 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-30 |
| These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 1982 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-30 |
| Hailey ® 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP) | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| Hailey ® Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, USP) Hailey ® Fe 1.5/30 (Each light green to green tablet contains 1.5 mg norethindrone acetate, USP and 30 mcg ethinyl estradiol, USP. Each brown to dark brown tablet contains 75 mg ferrous fumarate, USP). | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| MARLISSA ® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg) | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/ 0.02 mg Rx only | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| Norethindrone Acetate Tablets USP, 5 mg | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| These highlights do not include all the information needed to use ASHLYNA safely and effectively. See full prescribing information for ASHLYNA. ASHLYNA ® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets), for oral use Initial U.S. Approval: 1982 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| These highlights do not include all the information needed to use Charlotte ® 24 Fe safely and effectively. See full prescribing information for Charlotte 24 Fe. Charlotte 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets), for oral use Initial U.S. Approval: 1968 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| These highlights do not include all the information needed to use DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS. DROSPIRENONE AND ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 2001 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL. NORETHINDRONE ACETATE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 1968 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-29 |
| These highlights do not include all the information needed to use Tri-Estarylla safely and effectively. See full prescribing information for Tri-Estarylla. Tri-Estarylla ® (norgestimate and ethinyl estradiol, USP) tablets, for oral use Initial U.S. Approval: 1989 | Product name | A-S Medication Solutions | 2026-01-27 |
| HEATHER ® (Norethindrone Tablets, USP 0.35 mg) | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-23 |
| Hailey ® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, USP) | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2026-01-22 |
| ZAFEMY ® (norelgestromin and ethinyl estradiol transdermal system) These highlights do not include all the information needed to use ZAFEMY safely and effectively. See full prescribing information for ZAFEMY . ZAFEMY ® (norelgestromin and ethinyl estradiol transdermal system) Initial U.S. Approval: 2001 | Product name | AvKARE | 2026-01-19 |
| Norethindrone Acetate Tablets USP Rx Only 8492121/0625F | Product name | American Health Packaging | 2026-01-14 |
| Junel ® 21 Day (norethindrone acetate and ethinyl estradiol tablets USP) Junel ® Fe 28 Day (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay. | Product name | Preferred Pharmaceuticals Inc. | 2026-01-12 |
| These highlights do not include all the information needed to use FYAVOLV safely and effectively. See full prescribing information for FYAVOLV. Fyavolv TM (norethindrone acetate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1968 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-01-06 |
| ALYACEN 1/35(Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) | Product name | Proficient Rx LP | 2026-01-01 |
| Norethindrone Tablets USP | Product name | Proficient Rx LP | 2026-01-01 |
| Norethindrone Acetate Tablets USP Rx Only 8492121/0625F | Product name | American Health Packaging | 2025-12-29 |
| These highlights do not include all the information needed to use TYDEMY TM safely and effectively. See full prescribing information for TYDEMY TM . TYDEMY TM (drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets), for oral use Initial U.S. Approval: 2010 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-29 |
| Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg Rx only | Product name | Apotex Corp. | Naari Pte.Limited | Naari Pharma Private Limited | Aspen Oss B.V. | 2025-12-22 |
| These highlights do not include all the information needed to use ORIAHNN safely and effectively. See full prescribing information for ORIAHNN. ORIAHNN ® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), co-packaged for oral use Initial U.S. Approval: 2020 | Product name | AbbVie Inc. | 2025-12-19 |
| These highlights do not include all the information needed to use SAFYRAL safely and effectively. See full prescribing information for SAFYRAL. SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) for oral use Initial U.S. Approval: 2010 | Product name | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | Bayer AG | Sharp Corporation | 2025-12-19 |
| These highlights do not include all the information needed to use FYAVOLV safely and effectively. See full prescribing information for FYAVOLV. Fyavolv TM (norethindrone acetate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1968 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-17 |
| These highlights do not include all the information needed to use DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS safely and effectively. See full prescribing information for safely and effectively. See full prescribing information for DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM . DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS, for oral use Initial U.S. Approval: 2010 | Product name | Sandoz Inc | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | Bayer AG | Sharp Corporation | 2025-12-16 |
| These highlights do not include all the information needed to use OCELLA safely and effectively. See full prescribing information for OCELLA. OCELLA (drospirenone/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 2001 | Product name | TEVA PHARMACEUTICALS USA, INC. | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | Bayer AG | 2025-12-16 |
| Enskyce TM (desogestrel and ethinyl estradiol tablets USP) 0.15 mg/0.03 mg Rx Only | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-12 |
| These highlights do not include all the information needed to use DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS. DROSPIRENONE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 2001 | Product name | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 2025-12-12 |
| These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 1982 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-11 |
| Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mg | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-09 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE AND ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 1989 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-09 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE and ETHINYL ESTRADIOL tablets USP, for oral use Initial U.S. Approval: 1989 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-09 |
| These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1989 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-09 |
| Jencycla TM (norethindrone tablets USP, 0.35 mg) | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-08 |
| These highlights do not include all the information needed to use DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS safely and effectively. See full prescribing information for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS. DROSPIRENONE, ETHINYL ESTRADIOL and LEVOMEFOLATE CALCIUM Tablets and LEVOMEFOLATE CALCIUM Tablets, for oral use Initial U.S. Approval: 2010 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-08 |
| These highlights do not include all the information needed to use NIKKI safely and effectively. See full prescribing information for NIKKI. NIKKI TM (Drospirenone / ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 2001 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-08 |
| Dasetta 1/35 | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| DASETTATM 7/7/7 (norethindrone/ethinyl estradiol Tablets, USP) | Product name | Northstar Rx LLC | 2025-12-05 |
| DEBLITANE (Norethindrone Tablets, USP 0.35 mg) | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| ELINEST™ (Norgestrel and Ethinyl Estradiol Tablets, USP) Rx only | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| LARIN TM Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution. | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| LARIN™ 1.5/30 （Norethindrone Acetate and Ethinyl Estradiol Tablets, USP） | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| LARIN™ 1/20 Norethindrone Acetate and Ethinyl Estradiol Tablets, USP | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| LARIN™ Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution. | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| LEVONEST™ (Levonorgestrel and Ethinyl Estradiol Tablets USP, Triphasic Regimen) | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| PHILITH TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx Only | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| Pimtrea TM Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP 0.15 mg/0.02 mg and 0.01 mg | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| SHAROBEL™ (Norethindrone Tablets, USP) | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| These highlights do not include all the information needed to use BALCOLTRA ® safely and effectively. See Full Prescribing Information for BALCOLTRA ® . BALCOLTRA ® (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) for oral administration Initial U.S. Approval: 1997 | Product name | Avion Pharmaceuticals | Novast Laboratories, Ltd. | 2025-12-05 |
| These highlights do not include all the information needed to use ESTRADIOL AND NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL AND NORETHINDRONE ACETATE TABLETS. ESTRADIOL and NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 1998 | Product name | Ingenus Pharmaceuticals, LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| These highlights do not include all the information needed to use LARIN 24 Fe safely and effectively. See Full Prescribing Information for LARIN 24 Fe LARIN 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) for Oral Use Initial U.S. Approval:1968 | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS safely and effectively. See Full Prescribing Information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets and FERROUS BISGLYCINATE tablets for oral administration Initial U.S. Approval: 1997 | Product name | Acella Pharmaceuticals | Novast Laboratories, Ltd. | 2025-12-05 |
| These highlights do not include all the information needed to use Mibelas 24 Fe safely and effectively. See full prescribing information for Mibelas 24 Fe. Mibelas TM 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets), for oral use Initial U.S. Approval: 1968 | Product name | Lupin Pharmaceuticals, Inc. | Lupin Atlantis Holdings SA | LUPIN LIMITED | 2025-12-05 |
| These highlights do not include all the information needed to use SETLAKIN safely and effectively. See full prescribing information for SETLAKIN. SETLAKIN (levonorgestrel and ethinyl estradiol tablets) for oral use Initial U.S. Approval:1982 | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| These highlights do not include all the information needed to use Tri-Linyah safely and effectively. See full prescribing information for Tri-Linyah. Tri-Linyah (norgestimate/ethinyl estradiol) tablets, for oral use. Initial U.S. Approval: 1989 | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| Turqoz TM (norgestrel and ethinyl estradiol tablets USP) 0.3 mg/0.03 mg | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-05 |
| WERA TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.5 mg/0.035 mg | Product name | Northstar Rx LLC | Novast Laboratories, Ltd. | 2025-12-05 |
| Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05 mg/0.03 mg, 0.075 mg/0.04 mg and 0.125 mg/0.03 mg Rx only | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-02 |
| These highlights do not include all the information needed to use DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS. DROSPIRENONE and ETHINYL ESTRADIOL Tablets, 3 mg/0.03 mg, for oral use Initial U.S. Approval: 2001. | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-02 |
| These highlights do not include all the information needed to use KAITLIB TM FE safely and effectively. See full prescribing information for KAITLIB FE. KAITLIB Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets), for oral use Initial U.S. Approval: 1974 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-02 |
| Kurvelo™ (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/30 mcg)Rx only | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-11-28 |
| Norethindrone Tablets USP, 0.35 mg Rx only Revised: November 2025 | Product name | Apotex Corp. | Naari Pte. Limited | Naari Pharma Private Limited | Aspen Oss B.V. | 2025-11-28 |
| These highlights do not include all the information needed to use DROSPIRENONE and ETHINYL ESTRADIOL tablets safely and effectively. See full prescribing information for DROSPIRENONE and ETHINYL ESTRADIOL tablets. DROSPIRENONE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 2001 | Product name | Apotex Corp. | Naari Pte.Limited | Naari Pharma Private Limited | Newchem Spa | Industriale Chimica SRL | Aspen Oss B.V. | 2025-11-28 |
| These highlights do not include all the information needed to use WYMZYA Fe safely and effectively. See Full Prescribing Information for WYMZYA Fe. WYMZYA Fe [norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets] for oral use Initial U.S. Approval: 1975 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-11-19 |
| Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-11-19 |