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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 206694

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NDA 206694 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 206694

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

Medical Subject Heading (MeSH) Categories for 206694

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:	Oct 27, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Oct 27, 2017	TE:	AB	RLD:	No

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