Contraception
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FDA approval · 2019-03-11FDA Approved: NIKKI — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for NIKKI, a generic drospirenone/ethinyl estradiol combination oral contracept…
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FDA approval · 2019-01-24FDA Approved: LOJAIMIESS — Supplemental Application (Xiromed LLC)
FDA approved a supplemental application for LOJAIMIESS, a combination oral contraceptive manufactured by Xiromed LLC.
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FDA approval · 2018-12-07FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for DROSPIRENONE AND ETHINYL ESTRADIOL from Mylan Pharmaceuticals Inc., enabling the generic oral co…
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FDA approval · 2018-11-05FDA Approved: NORETHINDRONE ACETATE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for norethindrone acetate, allowing Ingenus Pharmaceuticals, LLC to market a generic norethindrone ace…
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FDA approval · 2018-09-26FDA Approved: BLISOVI FE 1/20 — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin's supplemental application for BLISOVI FE 1/20, a generic oral contraceptive containing norethindrone acetate and ethinyl…
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FDA approval · 2018-06-13FDA Approved: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic version of a combined oral contraceptive containing drospirenone, ethinyl estradiol and levomefo…
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FDA approval · 2018-06-05FDA Approved: HAILEY 1.5/30 — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved HAILEY 1.5/30, a generic combination oral contraceptive containing norethindrone acetate and ethinyl estradiol, under ANDA for …
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FDA approval · 2018-02-27FDA Approved: DROSPIRENONE AND ETHINYL ESTRADIOL — Original Application (NorthStar Rx LLC)
FDA approved the original application for a generic drospirenone/ethinyl estradiol product (DROSPIRENONE AND ETHINYL ESTRADIOL) manufactured…
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FDA approval · 2017-12-27FDA Approved: JAIMIESS — Original Application (Xiromed, LLC.)
FDA approved the original application for JAIMIESS, a combined oral contraceptive, by Xiromed, LLC.
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FDA approval · 2017-11-21FDA Approved: HAILEY FE 1/20 — Original Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved HAILEY FE 1/20 as a generic oral contraceptive under an original ANDA, containing norethindrone acetate, ethinyl estradiol,…
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FDA approval · 2017-10-10FDA Approved: LO LOESTRIN FE — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for LO LOESTRIN FE from Allergan, Inc. The product is a combination oral contraceptive used for …
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FDA approval · 2017-09-11FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original application for a generic fixed-dose combination of norethindrone acetate, ethinyl estradiol, and ferrous fumarate…
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FDA approval · 2017-08-09FDA Approved: NUVARING — Supplemental Application (Advanz Pharma (US) Corp.)
FDA approved a supplemental application for NuvaRing (etonogestrel and ethinyl estradiol) submitted by Advanz Pharma (US) Corp.
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FDA approval · 2017-08-09FDA Approved: YAZ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for YAZ, a combined oral contraceptive containing drospirenone and ethinyl estradiol, by Bayer H…
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FDA approval · 2017-08-09FDA Approved: DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium (Sandoz).
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FDA approval · 2017-08-09FDA Approved: SAFYRAL — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for SAFYRAL from Bayer HealthCare Pharmaceuticals. SAFYRAL is a combination oral contraceptive c…
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FDA approval · 2017-08-09FDA Approved: LEVORA — Supplemental Application (Mayne Pharma Inc.)
FDA supplemental application approval for LEVORA (levonorgestrel and ethinyl estradiol) submitted by Mayne Pharma Inc.
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FDA approval · 2017-08-09FDA Approved: PORTIA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for PORTIA, a combined oral contraceptive containing levonorgestrel and ethinyl estradiol, submi…
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FDA approval · 2017-08-09FDA Approved: ISIBLOOM — Supplemental Application (Xiromed, LLC.)
FDA approved a supplemental application for ISIBLOOM, a combination oral contraceptive containing desogestrel and ethinyl estradiol, manufac…
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FDA approval · 2017-08-09FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves a supplemental application for Levonorgestrel and Ethinyl Estradiol by Lupin Pharmaceuticals, Inc., supporting its use as a com…
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FDA approval · 2017-08-09FDA Approved: VALTYA 1/35 — Supplemental Application (Xiromed LLC)
FDA approved a supplemental application for VALTYA 1/35 (ethynodiol diacetate and ethinyl estradiol) by Xiromed LLC, enabling continued supp…
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FDA approval · 2017-08-09FDA Approved: CHATEAL EQ — Supplemental Application (Afaxys Pharma, LLC)
FDA approves a supplemental application for CHATEAL EQ (levonorgestrel and ethinyl estradiol) by Afaxys Pharma, LLC.
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FDA approval · 2017-08-09FDA Approved: VOLNEA — Supplemental Application (Xiromed, LLC.)
FDA approved a supplemental application for VOLNEA (desogestrel and ethinyl estradiol) from Xiromed, LLC.
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FDA approval · 2017-08-09FDA Approved: AVIANE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for AVIANE, a fixed-dose combination oral contraceptive containing levonorgestrel and ethinyl es…
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FDA approval · 2017-08-09FDA Approved: TAYTULLA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for TAYTULLA (norethindrone acetate and ethinyl estradiol, and ferrous fumarate), updating its label…