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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 | Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate Chewable Tablets, Barr Laboratories, Inc., Approval | Norethindrone Acetate, Ethinyl Estradiol and Ferrous Fumarate (ethinyl estradiol and norethindrone acetate) Tablets, Watson Laboratories, Inc., Approval | Norethindrone Acetate and Ethinyl Estradiol Tablets, Barr Laboratories, Inc., Approval | Norethindrone and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval | Norethindrone and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval | Norethindrone Acetate and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval | Norethindrone Acetate, Ethinyl Estradiol and Ferrous Fumarate Tablets, Watson Laboratories, Inc., Approval | Heather (norethindrone) Tablets, Glenmark Generics Ltd., Approval | Estradiol and Norethindrone Acetate Tablets, Barr Laboratories, Inc., Approval | Norethindrone Tablets, Glenmark Generics Ltd., Approval | Norethindrone, Ethinyl Estradiol and Ferrous Fumarate Chewable Tablets, Watson Laboratories, Inc., Tentative Approval | Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate, Tablets, Warner Chilcott, Approval | Cyclafem 7/7/7 (norethindrone and ethinyl estradiol) Tablets, Vintage Pharmaceuticals, Approval| Cyclafem 1/35 (norethindrone and ethinyl estradiol) Tablets, Vintage Pharmaceuticals, Approval | Briellyn (Norethindrone and Ethinyl Estradiol) Tablets, Glenmark Generics Inc., Approval | Estradiol and Norethindrone Acetate Tablets, Breckenridge Pharmaceutical, Inc., Chemistry New Strength | Norethindrone Tablets, Lupin Ltd., Approval | Norethindrone, Ethinyl Estradiol and Ferrous Fumarate Chewable Tablets, Watson Laboratories, Inc., Approval | Dasetta, norethindrone; ethinyl estradiol, Tablet; Oral, Novast Labs Ltd, Approval | Dasetta 1/35, ethinyl estradiol; norethindrone, Tablet; Oral-28, Novast Labs Ltd, Approval | Dasetta 7/7/7, ethinyl estradiol; norethindrone, Tablet; Oral-28, Novast Labs Ltd, Approval | Philith, ethinyl estradiol; norethindrone, Tablet; Oral-28, Novast Labs Ltd, Approval
  
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