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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Chinese Patent Office
Argus Health

Generated: July 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075797

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NDA 075797 describes TAMOXIFEN CITRATE, which is a drug marketed by Teva, Roxane, Actavis Labs Fl Inc, Mylan, Pharmachemie, Ivax Sub Teva Pharms, Mayne Pharma, Apotex, and Aegis Pharms, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the TAMOXIFEN CITRATE profile page.

The generic ingredient in TAMOXIFEN CITRATE is tamoxifen citrate. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

Summary for NDA: 075797

Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075797

Suppliers and Packaging for NDA: 075797

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tamoxifen citrate
TABLET;ORAL 075797 ANDA Teva Pharmaceuticals USA, Inc. 0093-0784 0093-0784-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-0784-05)
tamoxifen citrate
TABLET;ORAL 075797 ANDA Teva Pharmaceuticals USA, Inc. 0093-0784 0093-0784-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-0784-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 20, 2003TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Harvard Business School
Farmers Insurance
Chinese Patent Office
Fish and Richardson

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