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Details for New Drug Application (NDA): 076027

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NDA 076027 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: 076027

Tradename:
TAMOXIFEN CITRATE
Applicant:
Roxane
Ingredient:
tamoxifen citrate
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

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


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