Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Cryselle (Norgestrel & Ethinyl Estradiol) Tablets USP, 0.3 mg/0.03 mg, respectively, Duramed ANDA 75-840 Lo/Ovral & Lo/Ovral-28 (Noregestrel/Ethinyl Estradiol) Tablets & Nordette-21 & 28 (Levonorgetsrel/Ethinyl Estradiol) Tablets, Wyeth Ayerst NDA 17-612/S31, 17-802/S18, 18-668/S30, & 18-782/S23 Ogestrel 0.5/50-21 and Ogestrel 0.5/50-28 Tablets (Norgestrel and Ethinyl Estradiol Tablets USP, 0.5 mg and 0.05 mg, respectively) SCS ANDA 75-406 Ovral (norgestrel and ethinyl estradiol), Ovral-28 (norgestrel and ethinyl estradiol). Wyeth-Ayerst NDA 16-672/S-046 & 16-806/S-028 Overette (norgestrel) Tablets, Wyeth Pharmaceutical, Labeling Revision   For the latest approval information, locate this drug using this index.