Contraception

• FDA label_change · 2022-04-29
  FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Levonorgestrel and Ethinyl Estradiol from Mylan Pharmaceuticals, resulting in updated labeling f…

• FDA label_change · 2022-04-29
  FDA Approved: LEVORA — Supplemental Application (Mayne Pharma Inc.)

  The FDA approved a supplemental application for LEVORA (levonorgestrel and ethinyl estradiol) from Mayne Pharma, updating the product labeli…

• FDA label_change · 2022-01-25
  FDA Approved: TRI-MILI — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for TRI-MILI (norgestimate and ethinyl estradiol) from Aurobindo Pharma Limited, updating the produc…

• FDA label_change · 2019-10-28
  FDA Approved: AZURETTE — Supplemental Application (Mayne Pharma Inc.)

  FDA granted a supplemental approval for Azurette, updating its labeling for the desogestrel/ethinyl estradiol combination.

• FDA label_change · 2018-05-29
  FDA Approved: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a labeling supplement for a combined oral contraceptive containing norethindrone acetate, ethinyl estradiol, and ferrous fumara…

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• FDA label_change · 2016-08-26
  FDA Approved: NORTREL 7/7/7 (28 DAY REGIMEN) — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Nortrel 7/7/7 (28 day regimen), updating labeling to reflect a 28-day regimen for norethindrone …

• FDA label_change · 2013-09-13
  FDA Approved: SKYLA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for SKYLA (levonorgestrel intrauterine system) submitted by Bayer HealthCare Pharmaceuticals Inc. to…

• FDA label_change · 2013-08-07
  FDA Approved: SKYLA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for SKYLA (levonorgestrel) submitted by Bayer HealthCare Pharmaceuticals Inc. The approval updates S…

• FDA label_change · 2013-02-27
  FDA Approved: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a levonorgestrel and ethinyl estradiol combination contraceptive, updating …