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Generated: September 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074732

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NDA 074732 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 eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
Summary for 074732
Tradename:TAMOXIFEN CITRATE
Applicant:Mylan
Ingredient:tamoxifen citrate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 074732
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 074732 ANDA Mylan Pharmaceuticals Inc. 0378-0144 0378-0144-91 60 TABLET in 1 BOTTLE (0378-0144-91)
TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 074732 ANDA Mylan Pharmaceuticals Inc. 0378-0274 0378-0274-93 30 TABLET in 1 BOTTLE (0378-0274-93)

Profile for product number 001

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

Profile for product number 002

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

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