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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 090878

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NDA 090878 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 thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

Summary for 090878

Tradename:	TAMOXIFEN CITRATE
Applicant:	Apotex
Ingredient:	tamoxifen citrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 090878

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Sep 23, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Sep 23, 2011	TE:	AB	RLD:	No

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