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… Errin (Norethindrone) Tablets, 0.35 mg, Barr, ANDA 76-225 Estrostep (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Parke-Davis Pharmaceutical Research NDA 21-276 7/13/01 11/6/01 11/6/01 12/12/01 Estrostep (Norethindrone Acetate/ Ethinyl Estradiol) Tablets, Parke-Davis Pharmaceutical Research NDA 20-130/S07 7/01/01 4/25/03 Estrostep (Norethindrone Acetate/ Ethinyl Estradiol) Tablets, Pfizer, NDA 20-130/S009 6/14/02 6/17/02 Estrostep (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Parke-Davis Pharmaceutical Research NDA 20-130/S003 Femhrt (norethindrone acetate and ethinyl estradiol), tablets, [patient information] Parke-Davis NDA 21-065 Microgestin Fe 1/20 Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.0 mg/0.02 mg, Ferrous Fumarate Tablets, 75mg),Rx Watson, ANDA 75-647 2/5/01 3/5/01 Microgestin Fe 1.5/30 Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.5 mg and 0.03 mg, and Ferrous Fumarate Tablets, 75mg),Rx Watson, ANDA 75-548 Norethindrone Acetate Tablets USP, 5 mg, Barr, ANDA 75-951 Nortrel 7/7/7 (Norethindrone and Ethinyl Estradiol) Tablets USP, 0.5mg/0.035 mg, 0.75 mg/0.035 mg, and 1 mg/0.0.35 mg, Barr, ANDA 75-478 8/30/02 Nortrel 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP), 0.5mg/0.035 mg, 0.75 mg/0.035 mg, and 1 mg/0.0.35 mg, Barr, ANDA 75-478 Ortho Micronor (Norethindrone) Tablets, Johnson & Johnson NDA 16-954/S92 Ovcon 35 (norethindrone and ethinyl estradiol) tablets, chewable, Warner Chilcott Femhrt (norethindrone acetate/ethinyl estradiol), Tablets, Galen (Chemicals) Limited CombiPatch (estradiol/norethindrone acetate) transdermal system, Novartis Pharmaceuticals | Aranelle (Norethindrone & Ethinyl Estradiol) Tablets, Barr Laboratories, Approval | Nevis (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Barr Labs, Tentative Approval | Combipatch (estradiol/norethindrone acetate transdermal system), Novartis, Labeling Revision | Femhrt (norethindrone acetate/ethinyl estradiol tablets), Warner Chilcott Company, New Dosage Regimen | Norethindrone Acetate & Ethinyl Estradiol Tablets & Ferrous Fumate Tablets, Andrx Pharma, Approval | Norethindrone Acetate and Ethinyl Estradiol Tablets & Ferrous Fumarate Tablets, Andrx Pharma, Approval | Nor-QD (norethindrone) Tablets, Watson Labs, Labeling Revision | Combipatch (estradiol/norethindrone acetate transdermal system), Novartis Pharma, Labeling Revision | Loestrin 24 Fe (norethindrone acetate/ethinyl estradiol and ferrous fumarate) Tablets, Approval | Activella (estradiol/norethindrone acetate) tablets, Novo Nordisk, Labeling Revision & New Dosage | Ovcon 35 (norethindrone/ethinyl estradiol) Chewable Tablet, Warner Chilcott, Control Suppl. | Aygestin (norethindrone acetate) Tablets, Duramed Pharma, Formulation Revision | Tri-Legest-21 (Norethindrone Acetate and Ethinyl Estradiol) Tablets, Barr Labs, Approval | FEMCON Fe (norethindrone and ethinyl estradiol) Tablets, Warner Chilcott, Labeling Revision | Estradiol and Norethindrone Acetate Tablets, Breckenridge Pharma, Approval | Micronor (norethindrone) Tablets, Ortho McNeil Pharmaceutical, Inc., Labeling Revision | OVCON 50 (ethinyl estradiol and norethindrone) Tablets, Warner Chilcott, 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