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Generated: May 27, 2017

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 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 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. Twelve suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

Summary for NDA: 074732

Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 074732

Suppliers and Packaging for NDA: 074732

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tamoxifen citrate
TABLET;ORAL 074732 ANDA Mylan Pharmaceuticals Inc. 0378-0144 0378-0144-05 500 TABLET in 1 BOTTLE (0378-0144-05)
tamoxifen citrate
TABLET;ORAL 074732 ANDA Mylan Pharmaceuticals Inc. 0378-0144 0378-0144-91 60 TABLET in 1 BOTTLE (0378-0144-91)

Summary for product number 001

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

Summary for product number 002

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

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