Contraception
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FDA approval · 2022-02-10FDA Approved: NORTREL 21 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for Nortrel 21 Day, a generic combination oral contraceptive containing norethindrone and e…
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FDA approval · 2022-02-03FDA Approved: MONO-LINYAH — Supplemental Application (Northstar Rx LLC)
FDA approved a supplemental application for MONO-LINYAH, a combined oral contraceptive containing norg estimate and ethinyl estradiol, submi…
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FDA approval · 2022-02-03FDA Approved: NORGESTIMATE AND ETHINYL ESTRADIOL — Supplemental Application (AvKARE)
The FDA approved AvKARE's supplemental application for a generic combined oral contraceptive containing norgestimate and ethinyl estradiol.
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FDA approval · 2022-02-02FDA Approved: NORGESTIMATE AND ETHINYL ESTRADIOL — Supplemental Application (Naari Pte Limited)
FDA approves a supplemental application for the generic combined oral contraceptive Norgestimate and Ethinyl Estradiol from Naari Pte Limite…
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FDA approval · 2022-01-28FDA Approved: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for a combined oral contraceptive containing norethindrone, ethinyl estradiol, and ferrous fumar…
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FDA approval · 2022-01-27FDA Approved: TRI-SPRINTEC — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva Pharmaceuticals' supplemental application for Tri-SprinTEC, a generic combined oral contraceptive containing norgestim…
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FDA approval · 2022-01-25FDA Approved: VYLIBRA — Supplemental Application (Afaxys Pharma, LLC)
FDA approved a supplemental application for VYLIBRA (norgestimate and ethinyl estradiol) from Afaxys Pharma, LLC, expanding its labeling for…
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FDA approval · 2022-01-21FDA Approved: TRI-LO-MILI — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for TRI-LO-MILI (norgestimate and ethinyl estradiol) by Aurobindo Pharma Limited, authorizing its co…
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FDA approval · 2021-08-18FDA Approved: JUNEL 21 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Junel 21 Day (norethindrone acetate and ethinyl estradiol) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2021-08-18FDA Approved: JUNEL FE 28 DAY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for JUNEL FE 28 DAY, a combined oral contraceptive containing norethindrone acetate, ethinyl estradi…
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FDA approval · 2021-07-20FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approves a generic combination oral contraceptive containing norethindrone acetate, ethinyl estradiol, and ferrous fumarate under an Ori…
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FDA approval · 2021-01-13FDA Approved: ASHLYNA — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for ASHLYNA, a combined oral contraceptive containing levonorgestrel and ethinyl estradiol, manu…
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FDA approval · 2020-10-09FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Original Application (Apotex Corp.)
FDA approved Apotex Corp.’s original application for a generic levonorgestrel and ethinyl estradiol tablet. The product is a combined oral c…
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FDA approval · 2020-08-31FDA Approved: BLISOVI FE 1/20 — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin's supplemental application for BLISOVI FE 1/20, adding a 1/20 strength of the combined oral contraceptive norethindrone a…
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FDA approval · 2020-08-12FDA Approved: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for a generic oral contraceptive product containing drospirenone, ethinyl estradiol, and levomefolat…
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FDA approval · 2020-07-31FDA Approved: LARIN FE 1.5/30 — Supplemental Application (Northstar Rx LLC)
FDA approved a supplemental application to Northstar Rx LLC for LARIN FE 1.5/30, a combined oral contraceptive containing norethindrone acet…
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FDA approval · 2020-07-06FDA Approved: DASETTA 7/7/7 — Supplemental Application (Northstar Rx LLC)
The FDA approved a supplemental application for DASETTA 7/7/7 (norethindrone and ethinyl estradiol) from Northstar Rx LLC, confirming approv…
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FDA approval · 2020-04-28FDA Approved: LORYNA — Supplemental Application (Xiromed, LLC.)
FDA approved a supplemental application for LORYNA (drospirenone and ethinyl estradiol tablets) from Xiromed, LLC.
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FDA approval · 2020-03-30FDA Approved: TYBLUME — Original Application (Exeltis USA, Inc.)
FDA approves TYBLUME, a new combination oral contraceptive containing levonorgestrel and ethinyl estradiol, under the original application f…
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FDA approval · 2019-10-28FDA Approved: CYRED EQ — Supplemental Application (Afaxys Pharma, LLC)
The FDA approved a supplemental application for CYRED EQ, a desogestrel/ethinyl estradiol oral contraceptive, submitted by Afaxys Pharma, LL…
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FDA approval · 2019-09-09FDA Approved: MIBELAS 24 FE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin's supplemental application for MIBELAS 24 FE, a norethindrone acetate/ethinyl estradiol/ferrous fumarate combination oral…
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FDA approval · 2019-05-02FDA Approved: RESTART — Original Application (Winx Health Inc.)
FDA approves Winx Health Inc.'s original application for RESTART (levonorgestrel), bringing a generic contraceptive to market.
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FDA approval · 2019-04-26FDA Approved: NORGESTIMATE AND ETHINYL ESTRADIOL — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for Norgestimate and Ethinyl Estradiol, a combined oral contraceptive.
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FDA approval · 2019-04-03FDA Approved: ESTRADIOL AND NORETHINDRONE ACETATE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved Ingenus Pharmaceuticals' Estradiol and norethindrone acetate as a generic product under ANDA210612.
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FDA approval · 2019-03-22FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic drospirenone and ethinyl estradiol combination tablet under an original application (ANDA 21194…