Contraception
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FDA approval · 2013-10-09FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved Mylan's generic combination oral contraceptive Levonorgestrel and Ethinyl Estradiol under an Original Abbreviated New Drug …
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FDA approval · 2013-10-04FDA Approved: NUVARING — Supplemental Application (Advanz Pharma (US) Corp.)
The FDA approved a supplemental application for Nuvaring (etonogestrel and ethinyl estradiol) filed by Advanz Pharma (US) Corp., approving t…
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FDA approval · 2013-08-26FDA Approved: MICROGESTIN FE 1/20 — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved Microgestin FE 1/20 (norethindrone acetate/ethinyl estradiol with ferrous fumarate) under an Original Application (ANDA) for co…
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FDA approval · 2013-08-23FDA Approved: LARIN FE 1.5/30 — Original Application (Northstar Rx LLC)
FDA approved Northstar Rx LLC's original application for LARIN FE 1.5/30, a generic combined oral contraceptive containing norethindrone ace…
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FDA approval · 2013-08-07FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for MIRENA (levonorgestrel) from Bayer HealthCare Pharmaceuticals Inc., indicating an approved a…
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FDA approval · 2013-08-01FDA Approved: AZURETTE — Original Application (Mayne Pharma Inc.)
FDA approved Mayne Pharma's Azurette, an oral contraceptive containing desogestrel and ethinyl estradiol under an original ANDA submission.
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FDA approval · 2013-07-12FDA Approved: DESOGESTREL AND ETHINYL ESTRADIOL — Original Application (Mayne Pharma Inc.)
FDA approves Mayne Pharma's desogestrel and ethinyl estradiol as an Original Application generic contraceptive product.
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FDA approval · 2013-05-08FDA Approved: LO LOESTRIN FE — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for LO LOESTRIN FE by Allergan, Inc., extending the product's labeling/approval as a combined or…
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FDA approval · 2013-03-29FDA Approved: ALYACEN 1/35 — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for ALYACEN 1/35 (norethindrone and ethinyl estradiol) from Glenmark Pharmaceuticals Inc., USA, auth…
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FDA approval · 2013-01-31FDA Approved: SPRINTEC — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for SPRINTEC, a combination oral contraceptive containing norgestimate and ethinyl estradiol, from T…
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FDA approval · 2013-01-31FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for a combination oral contraceptive containing levonorgestrel and ethin…
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FDA approval · 2013-01-30FDA Approved: NORGESTIMATE AND ETHINYL ESTRADIOL — Original Application (AvKARE)
FDA approves AvKARE's generic oral contraceptive combination of norgestimate and ethinyl estradiol through an original ANDA submission.
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FDA approval · 2013-01-18FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic oral contraceptive combination levonorgestrel and ethinyl estradiol under an Original Applicatio…
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FDA approval · 2012-10-17FDA Approved: KURVELO — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Kurvelo, a generic combination oral contraceptive containing levonorgestrel and ethinyl estradiol, under an original ANDA from …
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FDA approval · 2012-09-19FDA 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 · 2012-07-31FDA Approved: ALYACEN 1/35 — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for ALYACEN 1/35, a generic combined oral contraceptive containing norethindrone and ethinyl estradi…
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FDA approval · 2012-06-28FDA Approved: NORGESTIMATE AND ETHINYL ESTRADIOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves a supplemental application for Norgestimate and Ethinyl Estradiol from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2012-06-25FDA Approved: TRI-LO-MARZIA — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' Tri-Lo-Marzia as an original-application generic oral contraceptive containing norgestimate and ethinyl …
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FDA approval · 2012-05-30FDA Approved: TRI-LINYAH — Original Application (Northstar Rx LLC)
FDA approved TRI-LINYAH, a generic combined oral contraceptive containing norgestimate and ethinyl estradiol, under an original application …
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FDA approval · 2012-05-23FDA Approved: MONO-LINYAH — Original Application (Northstar Rx LLC)
FDA approved MONO-LINYAH (norgestimate and ethinyl estradiol) from Northstar Rx LLC under an original application, a combined oral contracep…
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FDA approval · 2012-04-05FDA Approved: NORGESTIMATE AND ETHINYL ESTRADIOL — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved the original application for NORGESTIMATE AND ETHINYL ESTRADIOL, a generic oral contraceptive from Glenmark Pharmaceuticals Inc…
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FDA approval · 2012-03-27FDA Approved: WERA — Original Application (Northstar Rx LLC)
FDA approved the original application for WERA, a generic norethindrone/ethinyl estradiol oral contraceptive manufactured by Northstar Rx LL…
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FDA approval · 2012-02-13FDA Approved: SAFYRAL — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) filed by …
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FDA approval · 2011-12-22FDA Approved: DASETTA 7/7/7 — Original Application (Northstar Rx LLC)
FDA approved the generic product DASETTA 7/7/7 containing norethindrone and ethinyl estradiol under ANDA090946 by Northstar Rx LLC. The prod…
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FDA approval · 2011-08-02FDA Approved: SYEDA — Supplemental Application (Xiromed, LLC.)
FDA approved a supplemental application for SYEDA, a drospirenone and ethinyl estradiol combination oral contraceptive, manufactured by Xiro…