Contraception
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FDA approval · 2015-10-28FDA Approved: BLISOVI 24 FE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved BLISOVI 24 FE as an original application for a generic combination oral contraceptive containing norethindrone acetate and ethi…
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FDA approval · 2015-10-22FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for MIRENA (levonorgestrel-releasing intrauterine system) from Bayer HealthCare Pharmaceuticals …
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FDA approval · 2015-08-21FDA Approved: NATAZIA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for NATAZIA, a combined oral contraceptive containing estradiol valerate and estradiol valerate/…
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FDA approval · 2015-08-17FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Original Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's generic oral contraceptive product containing drospirenone and ethinyl estradiol under an Original Application (…
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FDA approval · 2015-08-12FDA Approved: ISIBLOOM — Original Application (Xiromed, LLC.)
FDA approved ISIBLOOM, a generic oral contraceptive containing desogestrel and ethinyl estradiol, via an Original Application (ANDA) by Xiro…
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FDA approval · 2015-07-22FDA Approved: TAYTULLA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for TAYTULLA, a combination oral contraceptive, submitted by Allergan, Inc.
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FDA approval · 2015-06-17FDA Approved: LOJAIMIESS — Original Application (Xiromed LLC)
FDA approved LOJAIMIESS from Xiromed LLC as an original application for a combined levonorgestrel and ethinyl estradiol contraceptive tablet…
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FDA approval · 2015-06-12FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Original Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's levonorgestrel and ethinyl estradiol combination via an Original Application, establishing a new approved oral c…
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FDA approval · 2015-05-21FDA Approved: VIENVA — Original Application (Xiromed, LLC.)
The FDA approved VIENVA (levonorgestrel and ethinyl estradiol) under the Original Application for ANDA 201088. Xiromed, LLC is the manufactu…
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FDA approval · 2015-05-16FDA Approved: ALYACEN 7/7/7 — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for ALYACEN 7/7/7, a generic norethindrone/ethinyl estradiol oral contraceptive.
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FDA approval · 2015-05-16FDA Approved: ALYACEN 1/35 — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for ALYACEN 1/35, a generic combination product of norethindrone and ethinyl estradiol for contracep…
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FDA approval · 2015-04-21FDA Approved: INTROVALE — Original Application (Xiromed LLC)
The FDA approved INTROVALE from Xiromed LLC as an original application for a generic levonorgestrel and ethinyl estradiol tablet for contrac…
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FDA approval · 2015-04-01FDA Approved: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved an abbreviated new drug application for norethindrone and ethinyl estradiol and ferrous fumarate as a generic oral contraceptiv…
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FDA approval · 2015-02-23FDA Approved: ASHLYNA — Original Application (Glenmark Pharmaceuticals Inc., USA)
ASHLYNA is a generic oral contraceptive approved by the FDA under an original application (ANDA 203163) containing levonorgestrel and ethiny…
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FDA approval · 2015-01-07FDA Approved: JINTELI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for JINTELI, providing approval related to its norethindrone acetate and ethinyl estradiol formu…
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FDA approval · 2014-12-19FDA Approved: MONO-LINYAH — Supplemental Application (Northstar Rx LLC)
FDA approved the supplemental application for MONO-LINYAH (norgestimate and ethinyl estradiol) by Northstar Rx LLC.
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FDA approval · 2014-09-30FDA Approved: YASMIN — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for YASMIN (drospirenone and ethinyl estradiol) submitted by Bayer HealthCare Pharmaceuticals.
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FDA approval · 2014-05-29FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA has approved a supplemental application for MIRENA (levonorgestrel) submitted by Bayer HealthCare Pharmaceuticals.
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FDA approval · 2014-05-08FDA Approved: SKYLA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for SKYLA (levonorgestrel), Bayer's intrauterine contraceptive device, resulting in labeling updates…
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FDA approval · 2014-04-16FDA Approved: XULANE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved an original application for XULANE, a generic norelgestromin and ethinyl estradiol contraceptive patch from Mylan Pharmaceutica…
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FDA approval · 2014-03-20FDA Approved: LARIN 1.5/30 — Original Application (Northstar Rx LLC)
FDA approved LARIN 1.5/30 (norethindrone acetate/ethinyl estradiol) under an original ANDA from Northstar Rx LLC for contraception. The prod…
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FDA approval · 2014-02-25FDA Approved: BRIELLYN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for BRIELLYN, a norethindrone and ethinyl estradiol oral contraceptive from Glenmark Pharmaceuti…
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FDA approval · 2014-02-21FDA Approved: PORTIA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for PORTIA (levonorgestrel and ethinyl estradiol) from Teva Pharmaceuticals USA, Inc., updating …
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FDA approval · 2014-01-28FDA Approved: KURVELO — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Kurvelo (levonorgestrel and ethinyl estradiol) by Lupin Pharmaceuticals, Inc.
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FDA approval · 2013-11-14FDA Approved: FEIRZA 1/20 — Original Application (Xiromed LLC)
FDA approved FEIRZA 1/20 from Xiromed LLC as an original ANDA for a combined oral contraceptive containing norethindrone acetate and ethinyl…