| 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. | PD-Rx Pharmaceuticals, Inc. | 20260521 | 18 |
| Turqoz TM (norgestrel and ethinyl estradiol tablets USP) 0.3 mg/0.03 mg | A-S Medication Solutions | 20260521 | 1 |
| Kurvelo™ (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/30 mcg)Rx only | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20260520 | 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 | Apotex Corp. | Naari Pte.Limited | 20260514 | 3 |
| NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal system | Zydus Lifesciences Limited | 20260416 | 2 |
| 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 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20260416 | 3 |
| WERA TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.5 mg/0.035 mg | Northstar Rx LLC | Novast Laboratories, Ltd. | 20260415 | 14 |
| DASETTATM 7/7/7 (norethindrone/ethinyl estradiol Tablets, USP) | Northstar Rx LLC | Novast Laboratories, Ltd. | 20260414 | 14 |
| Levonorgestrel and Ethinyl Estradiol Tablets USP Rx only | Apotex Corp. | Naari Pte Limited | Naari Pharma Private Limited | 20260404 | 1 |
| Levonorgestrel and Ethinyl Estradiol Tablets USP 0.15mg/0.03 mg | Apotex Corp. | Naari Pte Limited | Naari Pharma Private Limited | 20260403 | 1 |
| Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/ 0.02 mg Rx only | A-S Medication Solutions | 20260326 | 7 |
| 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 | Teva Pharmaceuticals, Inc. | 20260324 | 3 |
| Junel FE | Direct_Rx | 20260317 | 3 |
| 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 | Sandoz Inc | Bayer HealthCare Pharmaceuticals Inc. | 20260304 | 17 |
| 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 | TEVA PHARMACEUTICALS USA, INC. | Bayer HealthCare Pharmaceuticals Inc. | 20260304 | 28 |
| 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 | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | 20260304 | 23 |
| Cryselle ® (norgestrel and ethinyl estradiol tablets, USP) | A-S Medication Solutions | 20260303 | 1 |
| 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 | A-S Medication Solutions | 20260303 | 12 |
| 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 | A-S Medication Solutions | 20260303 | 12 |
| VIENVA TM | A-S Medication Solutions | 20260303 | 7 |
| 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 | Bayer HealthCare Pharmaceuticals Inc. | Sharp Corporation | Bayer AG | 20260302 | 23 |
| Rx only | Dr. Reddy’s Laboratories Inc. | Novast Laboratories, Ltd. | 20260213 | 1 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260206 | 17 |
| 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) | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260131 | 10 |
| BRIELLYN ® (Norethindrone and Ethinyl Estradiol Tablets, USP) | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260131 | 13 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Cyndea Pharma SL | 20260131 | 3 |
| VIORELE ® (Desogestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.02 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) Rx only | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260131 | 17 |
| Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.09 mg/0.02 mg | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260130 | 10 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260130 | 11 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260130 | 6 |
| Hailey ® 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP) | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 9 |
| 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). | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 11 |
| MARLISSA ® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg) | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 14 |
| Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/ 0.02 mg Rx only | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 7 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 10 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 4 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 9 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260129 | 6 |
| 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 | A-S Medication Solutions | 20260127 | 3 |
| Hailey ® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, USP) | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260122 | 9 |
| 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 | AvKARE | 20260119 | 2 |
| 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. | Preferred Pharmaceuticals Inc. | 20260112 | 10 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20260106 | 18 |
| ALYACEN 1/35(Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) | Proficient Rx LP | 20260101 | 2 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251229 | 8 |
| Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg Rx only | Apotex Corp. | Naari Pte.Limited | Naari Pharma Private Limited | Aspen Oss B.V. | 20251222 | 1 |
| Enskyce TM (desogestrel and ethinyl estradiol tablets USP) 0.15 mg/0.03 mg Rx Only | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251212 | 4 |
| 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 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20251212 | 6 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251211 | 14 |
| Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mg | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251209 | 9 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251209 | 10 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251209 | 8 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251209 | 14 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251208 | 9 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251208 | 8 |
| Dasetta 1/35 | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 12 |
| ELINEST™ (Norgestrel and Ethinyl Estradiol Tablets, USP) Rx only | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 7 |
| 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. | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 10 |
| LARIN™ 1.5/30 （Norethindrone Acetate and Ethinyl Estradiol Tablets, USP） | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 10 |
| LARIN™ 1/20 Norethindrone Acetate and Ethinyl Estradiol Tablets, USP | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 7 |
| LARIN™ Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution. | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 9 |
| LEVONEST™ (Levonorgestrel and Ethinyl Estradiol Tablets USP, Triphasic Regimen) | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 9 |
| PHILITH TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx Only | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 8 |
| Pimtrea TM Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP 0.15 mg/0.02 mg and 0.01 mg | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 8 |
| 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 | Avion Pharmaceuticals | Novast Laboratories, Ltd. | 20251205 | 6 |
| 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 | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 9 |
| 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 | Acella Pharmaceuticals | Novast Laboratories, Ltd. | 20251205 | 5 |
| 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 | Lupin Pharmaceuticals, Inc. | Lupin Atlantis Holdings SA | LUPIN LIMITED | 20251205 | 7 |
| 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 | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 9 |
| 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 | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 11 |
| Turqoz TM (norgestrel and ethinyl estradiol tablets USP) 0.3 mg/0.03 mg | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251205 | 13 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251202 | 7 |
| 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. | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251202 | 7 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251202 | 14 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251119 | 15 |
| Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251119 | 6 |
| Blisovi TM Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*) 1.5 mg/0.03 mg *Ferrous fumarate tablets are not USP for dissolution | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251118 | 2 |
| Blisovi TM Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*) 1 mg/0.02 mg | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251118 | 16 |
| Rx only | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251118 | 11 |
| These highlights do not include all the information needed to use BLISOVI 24 Fe safely and effectively. See Full Prescribing Information for BLISOVI 24 Fe. Blisovi TM 24 Fe [norethindrone acetate and ethinyl estradiol tablets USP, (1 mg/0.02 mg) and ferrous fumarate tablets, (75 mg)] for Oral Use Initial U.S. Approval: 1968 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251118 | 8 |
| These highlights do not include all the information needed to use NuvaRing safely and effectively. See full prescribing information for NuvaRing. NuvaRing ® (etonogestrel/ethinyl estradiol vaginal ring) Initial U.S. Approval: 2001 | Organon LLC | 20251114 | 10 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251113 | 18 |
| Microgestin® 1/20 Norethindrone Acetate/Ethinyl Estradiol Tablets, USP | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20251112 | 2 |
| These highlights do not include all the information needed to use ROSYRAH, safely and effectively. See full prescribing information for ROSYRAH. ROSYRAH, for oral use Initial U.S. Approval: 1982 | Xiromed, LLC | 20251110 | 2 |
| Zovia® 1/35 (Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg/35 mcg) Rx only | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20251110 | 3 |
| These highlights do not include all the information needed to use NuvaRing safely and effectively. See full prescribing information for NuvaRing. NuvaRing ® (etonogestrel/ethinyl estradiol vaginal ring) Initial U.S. Approval: 2001 | A-S Medication Solutions | 20251001 | 5 |
| 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 | Preferred Pharmaceuticals Inc. | 20251001 | 8 |
| 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 | Preferred Pharmaceuticals, Inc. | 20250924 | 8 |
| Necon ® (Norethindrone and Ethinyl Estradiol Tablets, USP, 0.5 mg/0.035 mg) | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20250909 | 2 |
| Azurette ® (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP 0.15 mg/0.02 mg and 0.01 mg) | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20250908 | 3 |
| Tilia® Fe(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) 1 mg/0.02 mg, 1 mg/0.03 mg, 1 mg/0.035 mg *Ferrous fumarate tablets are not USP for dissolution. | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20250908 | 3 |
| These highlights do not include all the information needed to use FEMLYV™ safely and effectively. See full prescribing information for FEMLYV. FEMLYV (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) Initial U.S. Approval: 1968 | Millicent US, Inc. | Patheon Inc. (Thermo Fisher Scientific) | 20250903 | 3 |
| Aubra EQ® (Levonorgestrel and Ethinyl Estradiol Tablets USP) 0.1 mg/0.02 mg Rx only Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. | Bryant Ranch Prepack | 20250819 | 2 |
| 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 | NorthStar Rx LLC | Aurobindo Pharma Limited | 20250807 | 1 |
| Microgestin® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution. | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20250804 | 2 |
| Afirmelle TM (Levonorgestrel and Ethinyl Estradiol Tablets USP) 0.1 mg/0.02 mg Rx only Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. | Aurobindo Pharma Limited | 20250801 | 10 |
| Aubra EQ® (Levonorgestrel and Ethinyl Estradiol Tablets USP) 0.1 mg/0.02 mg Rx only Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. | Afaxys Pharma, LLC | Aurobindo Pharma Limited | 20250801 | 10 |
| Ayuna ® (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) Rx only | Aurobindo Pharma Limited | 20250801 | 14 |
| Chateal EQ ® (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg) Rx only | Afaxys Pharma, LLC | Aurobindo Pharma Limited | 20250801 | 10 |
| These highlights do not include all the information needed to use SIMPESSE safely and effectively. See full prescribing information for SIMPESSE. SIMPESSE ® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 1982 | Aurobindo Pharma Limited | 20250801 | 12 |
| Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) | Mayne Pharma Inc. | Patheon Inc. | 20250728 | 14 |
| Lutera® (Levonorgestrel and Ethinyl Estradiol Tablets USP) | Mayne Pharma Inc. | Patheon, Inc. | 20250728 | 7 |
| LEVORA ® 0.15/30-28 (levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg tablets) | Mayne Pharma Inc. | Patheon, Inc. | 20250724 | 10 |
| SRONYX ® (Levonorgestrel and Ethinyl Estradiol Tablets USP) | Mayne Pharma Inc. | Patheon Inc. | 20250724 | 8 |
| Microgestin® 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP) | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20250709 | 3 |
| 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. | Bryant Ranch Prepack | 20250702 | 2 |
| AVERI™ Desogestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ferrous Bisglycinate Tablets, 36.5 mg | Avion Pharmaceuticals, LLC | 20250605 | 2 |
| Cyred EQ ® (Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg) Rx only | Bryant Ranch Prepack | 20250605 | 1 |
| These highlights do not include all the information needed to use YAZ safely and effectively. See full prescribing information for YAZ. YAZ® (drospirenone/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 2001 | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | Bayer AG | Sharp Corporation | 20250529 | 21 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20250512 | 17 |
| Blisovi TM Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*) 1.5 mg/0.03 mg *Ferrous Fumarate Tablets are not USP for dissolution | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20250508 | 8 |
| JUNEL FE 28 DAY | A-S Medication Solutions | 20250501 | 12 |
| 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 system) Initial U.S. Approval: 2018 | Mayne Pharma | Sever Pharma Solutions AB | Sharp Packaging Services, LLC | 20250423 | 5 |
| LUIZZA 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg) | Xiromed, LLC | Xiromed LLC | 20250421 | 1 |
| 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 | PD-Rx Pharmaceuticals, Inc. | 20250408 | 8 |
| 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 | PD-Rx Pharmaceuticals, Inc. | 20250408 | 15 |
| DOLISHALE TM (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets, USP | Ingenus Pharmaceuticals, LLC | Novast Laboratories, Ltd. | 20250401 | 2 |
| These highlights do not include all the information needed to use NuvaRing safely and effectively. See full prescribing information for NuvaRing. NuvaRing ® (etonogestrel/ethinyl estradiol vaginal ring) Initial U.S. Approval: 2001 | Advanz Pharma (US) Corp. | 20250321 | 2 |
| Portia ® (levonorgestrel and ethinyl estradiol tablets USP) Rx only | Teva Pharmaceuticals USA, Inc. | 20250312 | 15 |
| 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 | Teva Pharmaceuticals USA, Inc. | 20250312 | 17 |