Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com