Details for New Drug Application (NDA): 017970

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NDA 017970 describes NOLVADEX, which is a drug marketed by Astrazeneca and is included in one NDA. Additional details are available on the NOLVADEX profile page.

The generic ingredient in NOLVADEX 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 017970

Tradename:	NOLVADEX
Applicant:	Astrazeneca
Ingredient:	tamoxifen citrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 017970

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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 21, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 017970

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-001	Approved Prior to Jan 1, 1982	4,536,516*PED	⤷ Get Started Free
Astrazeneca	NOLVADEX	tamoxifen citrate	TABLET;ORAL	017970-002	Mar 21, 1994	4,536,516*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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