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… 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 | Estradiol and Estradiol/Norgestimate Tablets, Barr Labs, Tentative Approval | Estradiol & Estradiol/Norgestimate Tablets, Barr Labs, Approval | Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets, Ortho-McNeil Pharma, Approval | Norgestimate & Ethinyl Estradiol Tablets, Watson Labs, Approval | Ortho-Cyclen (norgestimate/ethinyl estradiol) Tablets, Johnson & Johnson, Labeling Revision | Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets, Johnson & Johnson, Labeling Revision | ORTHO-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation Revision | ORTHO TRI-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation 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