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… Nolvadex (tamoxifen citrate) Tablets, 20 mg, . Astra Zeneca NDA 21-109 17-970/S50 8/30/02 9/12/02 8/30/02 2/20/03 Nolvadex (tamoxifen citrate) Tablets, . AstraZeneca NDA 17-970/S49 FA, S51 1/30/03 2/12/03 7/5/03 Nolvadex (tamoxifen citrate) Tablets, . Astra Zeneca NDA 17-970/S37, S44 & S49 5/16/02 5/21/02 5/16/02 Nolvadex (tamoxifen citrate) Tablets, . Astra Zeneca NDA 17-970/S048 6/10/03 7/8/03 7/8/03 Nolvadex (tamoxifen citrate) Tablets, . Astra Zeneca NDA 17-970/S046 6/29/00 7/14/00 7/6/00 12/18/01 Nolvadex Indication: - In women with DCIS, following breast surgery and radiation, Nolvadex is indicated to reduce the risk of invasive breast cancer. Nolvadex (tamoxifen citrate) Tablets, . Tamoxifen Information Page Zeneca NDA 17-970/SE1-040 10/29/98 10/29/98 10/29/98 11/10/98 Nolvadex Indication- Reduce the incidence of breast cancer in women at high risk for breast cancer. Nolvadex (tamoxifen citrate) Tablets, Zeneca NDA 17-970/SE1-039 10/29/98 10/29/98 10/29/98 6/28/99 Nolvadex Indication- reduce the occurrence of contralateral breast cancer in patients receiving adjuvant Nolvadex therapy for breast cancer. Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Andrx ANDA 76-179 2/20/03 Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Andrx ANDA 76-179 7/10/02 Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Roxane ANDA 76-027 2/20/03 Tamoxifen Citrate Tablets USP, 10 mg (base), Teva ANDA 75-797 2/20/03 Tamoxifen Citrate Tablets USP, 10 mg (base), Teva USA ANDA 75-797 2/14/01 3/6/01 Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Ivax ANDA 75-740 2/20/03 Tamoxifen Citrate Tablets USP, 20 mg (base), Pharmachemie B.V. ANDA 74-858 2/20/03 Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Mylan Phrmaceuticals ANDA 74-732 2/20/03 Tamoxifen Citrate Tablets USP, 10 & 20 mg (base), Mylan Phrmaceuticals ANDA 74-732 3/21/02 10/29/02 Tamoxifen Citrate Tablets USP, 10 mg (base), Mylan Phrmaceuticals ANDA 74-732 6/26/00 10/30/00 Tamoxifen Citrate Tablets USP, 10 mg (base), Pharmachemie B.V. ANDA 74-539 3/21/02 10/29/02 Tamoxifen Citrate Tablets USP, 10 mg (base), Pharmachemie B.V. ANDA 74-539 5/31/00 6/6/00 Tamoxifen Citrate Tablets USP, 10 mg (base) and 20 mg (base), Teva ANDA 74-504 4/28/03 Tamoxifen Citrate Tablets USP, 10 mg (base) and 20 mg (base), Novopharm Limited ANDA 74-504 6/28/00 10/30/00 Tamoxifen Citrate Tablets USP, 10 mg (base) and 20 mg (base), Barr ANDA 70-929 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE AEGIS 076398 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE AEGIS 076179 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Andrx 076179 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE Andrx 017970 TAMOXIFEN CITRATE Tablet; 10MG BASE NOLVADEX ASTRAZENECA 017970 TAMOXIFEN CITRATE Tablet; 20MG BASE NOLVADEX ASTRAZENECA 070929 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Barr 070929 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE Barr 075740 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Ivax 075740 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE Ivax 074732 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Mylan 074732 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE Mylan 074539 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Pharmachemie 074858 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE Pharmachemie 076027 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Roxane 076027 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE Roxane 074504 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Teva 075797 TAMOXIFEN CITRATE Tablet; 10MG BASE TAMOXIFEN CITRATE Teva 074504 TAMOXIFEN CITRATE Tablet; 20MG BASE TAMOXIFEN CITRATE Teva   For the latest approval information, locate this drug using this index.