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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Chubb
Fish and Richardson
US Department of Justice
Cipla
Argus Health
Johnson and Johnson
Baxter
UBS

Generated: February 24, 2018

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 Actavis Labs Fl Inc, Aegis Pharms, Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
Summary for 075797
Tradename:TAMOXIFEN CITRATE
Applicant:Mayne Pharma
Ingredient:tamoxifen citrate
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075797
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 075797 ANDA Teva Pharmaceuticals USA, Inc. 0093-0784 E 0093-0784-86
TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 075797 ANDA Teva Pharmaceuticals USA, Inc. 0093-0784 E 0093-0784-10

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
Harvard Business School
McKesson
Cantor Fitzgerald
Merck
Argus Health
Accenture
Fish and Richardson

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