Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076179

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NDA 076179 describes TAMOXIFEN CITRATE, which is a drug marketed by Actavis Labs Fl Inc, Aegis Pharms, Apotex, Dr Reddys Labs Sa, Eugia Pharma, Ivax Sub Teva Pharms, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in twelve 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 is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

Summary for 076179

Tradename:	TAMOXIFEN CITRATE
Applicant:	Actavis Labs Fl Inc
Ingredient:	tamoxifen citrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 076179

Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Selective Estrogen Receptor Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Feb 20, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Feb 20, 2003	TE:		RLD:	No

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