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 | Nolvadex (tamoxifen citrate) Tablets, AstraZeneca, Labeling Revision | NOLVADEX (tamoxifen citrate) Tablets, AstraZeneca, Labeling Revision

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