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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074858

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NDA 074858 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: 074858

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 074858

Suppliers and Packaging for NDA: 074858

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMOXIFEN CITRATE
tamoxifen citrate
TABLET;ORAL 074858 ANDA Teva Pharmaceuticals USA, Inc. 0093-0782 0093-0782-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-0782-01)
TAMOXIFEN CITRATE
tamoxifen citrate
TABLET;ORAL 074858 ANDA Teva Pharmaceuticals USA, Inc. 0093-0782 0093-0782-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-0782-05)

Summary for product number 001

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


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