Contraception
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FDA approval · 2023-07-17FDA Approved: LARIN FE 1.5/30 — Supplemental Application (Northstar Rx LLC)
FDA approved a supplemental application for LARIN FE 1.5/30, a combined oral contraceptive containing norethindrone acetate/ethinyl estradio…
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FDA approval · 2023-07-14FDA Approved: TARINA 24 FE — Supplemental Application (Afaxys Pharma, LLC)
FDA approved a supplemental application for Tarina 24 FE, a combined oral contraceptive containing norethindrone acetate, ethinyl estradiol,…
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FDA approval · 2023-06-30FDA Approved: ETYQA — Original Application (Aurobindo Pharma Limited)
FDA approved ETYQA, a generic estradiol and norethindrone acetate combination tablet from Aurobindo Pharma Limited.
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FDA approval · 2023-06-22FDA Approved: MIBELAS 24 FE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin's supplemental application for MIBELAS 24 FE, a combination oral contraceptive containing norethindrone acetate, ethinyl …
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FDA approval · 2023-06-22FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application to permit Amneal Pharmaceuticals NY LLC to market a generic combination oral contraceptive containin…
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FDA approval · 2023-06-21FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL — Supplemental Application (Xiromed, LLC)
FDA approved a supplemental application for Xiromed, LLC to support the generic product of norethindrone acetate and ethinyl estradiol table…
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FDA approval · 2023-06-21FDA Approved: FINZALA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for FINZALA, a combined oral contraceptive containing norethindrone acetate, ethinyl estradiol, …
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FDA approval · 2023-06-02FDA Approved: MICROGESTIN 1/20 — Supplemental Application (Dr.Reddy's Laboratories Inc.)
FDA approved a supplemental application for Microgestin 1/20 (norethindrone acetate/ethinyl estradiol) from Dr. Reddy's Laboratories Inc., u…
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FDA approval · 2023-03-24FDA Approved: LOJAIMIESS — Supplemental Application (Xiromed LLC)
FDA approved a supplemental application for LOJAIMIESS (levonorgestrel and ethinyl estradiol tablets) from Xiromed LLC. The product is a gen…
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FDA approval · 2023-03-24FDA Approved: HER STYLE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
FDA approved a supplemental application for HER STYLE, a levonorgestrel-containing product manufactured by Ingenus Pharmaceuticals, LLC.
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FDA approval · 2023-02-03FDA Approved: KURVELO — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Kurvelo, a generic combined oral contraceptive containing levonorgestrel and ethinyl estradiol, …
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FDA approval · 2022-11-10FDA Approved: LILETTA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for LILETTA (levonorgestrel) submitted by Allergan, Inc.
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FDA approval · 2022-04-29FDA Approved: CAMRESE LO — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for CAMRESE LO (levonorgestrel/ethinyl estradiol) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2022-04-29FDA Approved: KARIVA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for KARIVA (desogestrel/ethinyl estradiol), maintaining regulatory approval for this combined oral c…
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FDA approval · 2022-04-29FDA Approved: AVIANE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for AVIANE (levonorgestrel and ethinyl estradiol) from Teva Pharmaceuticals USA, Inc. The approv…
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FDA approval · 2022-04-29FDA Approved: BRIELLYN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for BRIELLYN, a generic combined oral contraceptive containing norethindrone and ethinyl estradiol, …
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FDA approval · 2022-04-29FDA Approved: SPRINTEC — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for SPRINTEC (norgestimate and ethinyl estradiol) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2022-04-29FDA Approved: NORGESTIMATE AND ETHINYL ESTRADIOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for NORGESTIMATE AND ETHINYL ESTRADIOL from Glenmark Pharmaceuticals, enabling the generic oral cont…
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FDA approval · 2022-04-29FDA Approved: TRI-LINYAH — Supplemental Application (Northstar Rx LLC)
FDA approved a supplemental application for TRI-LINYAH (norgestimate and ethinyl estradiol) submitted by Northstar Rx LLC.
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FDA approval · 2022-04-29FDA Approved: KURVELO — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves a supplemental application for Kurvelo, a combined oral contraceptive containing levonorgestrel and ethinyl estradiol, submitte…
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FDA approval · 2022-04-29FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Levonorgestrel and Ethinyl Estradiol submitted by Lupin Pharmaceuticals, Inc.
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FDA approval · 2022-04-29FDA Approved: NORTREL 28 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Nortrel 28 Day (norethindrone and ethinyl estradiol) from Teva Pharmaceuticals USA, Inc. und…
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FDA approval · 2022-04-29FDA Approved: JOLESSA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2022-04-29FDA Approved: NORTREL 7/7/7 (28 DAY REGIMEN) — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Nortrel 7/7/7 (28-day regimen), a combined oral contraceptive containing norethindrone and e…
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FDA approval · 2022-04-29FDA Approved: MICROGESTIN 24 FE — Supplemental Application (Mayne Pharma Inc.)
FDA approved a supplemental application for Microgestin 24 FE (norethindrone acetate/ethinyl estradiol and ferrous fumarate) by Mayne Pharma…