Contraception
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FDA approval · 2026-07-28FDA Approved: GWYN LO — Original Application (Viatris Specialty LLC)
FDA approval of GWYN LO, a combined oral contraceptive containing norelgestromin and ethinyl estradiol, from Viatris Specialty LLC.
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FDA approval · 2025-06-20FDA Approved: ETYQA — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for ETYQA (estradiol and norethindrone acetate) from Aurobindo Pharma Limited. This action perta…
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FDA approval · 2025-06-18FDA Approved: TRI-LEGEST FE 28 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for TRI-LEGEST FE 28 DAY, a combined oral contraceptive containing norethindrone acetate and ethinyl…
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FDA approval · 2025-06-17FDA Approved: HAILEY FE 1/20 — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for HAILEY FE 1/20, a combination hormonal contraceptive containing norethindrone acetate, ethinyl e…
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FDA approval · 2025-06-16FDA Approved: MICROGESTIN 24 FE — Supplemental Application (Mayne Pharma Inc.)
FDA approved a supplemental application for MICROGESTIN 24 FE, a combined oral contraceptive containing norethindrone acetate/ethinyl estrad…
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FDA approval · 2025-05-22FDA Approved: LUTERA — Supplemental Application (Mayne Pharma Inc.)
FDA approved a supplemental application for LUTERA (levonorgestrel and ethinyl estradiol) submitted by Mayne Pharma Inc.
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FDA approval · 2025-02-24FDA Approved: MIUDELLA — Original Application (Sebela Women's Health Inc.)
FDA approved MIUDELLA, a copper intrauterine device, under Sebela Women's Health Inc.'s original application. It provides contraception by r…
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FDA approval · 2024-06-13FDA Approved: GEMMILY — Supplemental Application (Xiromed, LLC)
FDA approved a supplemental application for GEMMILY, a combination oral contraceptive containing norethindrone acetate, ethinyl estradiol, a…
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FDA approval · 2024-05-31FDA Approved: NUVARING — Supplemental Application (Advanz Pharma (US) Corp.)
FDA approved a supplemental application for Nuvaring (etonogestrel and ethinyl estradiol) by Advanz Pharma (US) Corp.
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FDA approval · 2024-05-06FDA Approved: KAITLIB FE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for KAITLIB FE (norethindrone and ethinyl estradiol) from Lupin Pharmaceuticals, Inc.
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FDA approval · 2024-04-05FDA Approved: LARIN 1.5/30 — Supplemental Application (Northstar Rx LLC)
The FDA approved a supplemental application for LARIN 1.5/30, a generic oral contraceptive containing norethindrone acetate and ethinyl estr…
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FDA approval · 2024-03-28FDA Approved: AUROVELA FE 1/20 — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for AUROVELA FE 1/20, a generic combined oral contraceptive containing norethindrone acetate, et…
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FDA approval · 2024-02-16FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for a norethindrone acetate and ethinyl estradiol oral contraceptive product from Glenmark.
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FDA approval · 2024-02-16FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL — Supplemental Application (Nivagen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for norethindrone acetate and ethinyl estradiol from Nivagen Pharmaceuticals, a combined oral co…
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FDA approval · 2024-02-01FDA Approved: TRI-ESTARYLLA — Supplemental Application (Xiromed, LLC.)
FDA approved a supplemental application for Tri-Estarylla (norgestimate and ethinyl estradiol) from Xiromed, LLC., supporting an additional …
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FDA approval · 2024-01-05FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for norethindrone acetate and ethinyl estradiol tablets (oral contraceptive) developed by Mylan Phar…
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FDA approval · 2024-01-03FDA Approved: MARLISSA — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves a supplemental application for MARLISSA (levonorgestrel and ethinyl estradiol) submitted by Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2023-10-24FDA Approved: NIKKI — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals’ supplemental application for NIKKI, a combined oral contraceptive containing drospirenone and ethinyl es…
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FDA approval · 2023-10-24FDA Approved: VESTURA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for VESTURA (drospirenone and ethinyl estradiol) from Teva, updating labeling to support its use…
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FDA approval · 2023-10-18FDA Approved: ESTRADIOL AND NORETHINDRONE ACETATE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
The FDA approved a supplemental application for Estradiol and Norethindrone Acetate from Ingenus Pharmaceuticals, LLC.
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FDA approval · 2023-09-28FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for a generic drospirenone/ethinyl estradiol contraceptive from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2023-09-25FDA Approved: JUNEL 21 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for JUNEL 21 DAY (norethindrone acetate and ethinyl estradiol) from Teva Pharmaceuticals USA, in…
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FDA approval · 2023-09-25FDA Approved: JUNEL FE 28 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for JUNEL FE 28 DAY (norethindrone acetate and ethinyl estradiol and ferrous fumarate) from Teva Pha…
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FDA approval · 2023-08-16FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Camber Pharmaceuticals' generic drospirenone/ethinyl estradiol, making this combined oral contra…
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FDA approval · 2023-08-09FDA Approved: BLISOVI FE 1.5/30 — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' BLISOVI FE 1.5/30 through a supplemental approval, adding a 1.5 mg norethindrone/30 mcg ethinyl estradio…