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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 076398

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NDA 076398 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 nine 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. Ten suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

Summary for 076398

Tradename:	TAMOXIFEN CITRATE
Applicant:	Aegis Pharms
Ingredient:	tamoxifen citrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 076398

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:	Mar 31, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Mar 31, 2003	TE:		RLD:	No

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