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… Ortho-Prefest (estradiol/norgestimate) Tablets, King NDA 21-040/S10 1/23/03 1/27/03 Ortho-Prefest (17b-estradiol and 17b-estradiol/norgestimate), tablets [Patient Information] R.W. Johsnons NDA 21-040 10/22/99 12/30/99 12/30/99 ORTHO TRI-CYCLEN Lo (norgestimate/ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. NDA 21-241 Sprintec-28 (Norgestimate & Ethinyl Estradiol) Tablets, 0.25 mg/0.035 mg respectively Barr, ANDA 75-804 Tri-Sprintec (Norgestimate and Ethinyl Estradiol) Tablets, 0.180 mg/0.035 mg, 0.215 mg/0.035, 0.250 mg/0.035 mg, Barr, Prefest (estradiol and norgestimate), King Pharmaceuticals Norgestimate and Ethinyl Tri-Previfem (Norgestimate and Ethinyl Estradiol) Tablets, Andrx Pharmaceuticals Estradiol Tablets, Andrx Pharmaceuticals PREFEST (estradiol/norgestimate) Tablets, King Pharmaceuticals, Labeling Revision   For the latest approval information, locate this drug using this index.