Details for New Drug Application (NDA): 021807

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NDA 021807 describes SOLTAMOX, which is a drug marketed by Mayne Pharma Commrcl and is included in one NDA. It is available from one supplier. Additional details are available on the SOLTAMOX profile page.

The generic ingredient in SOLTAMOX 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 021807

Tradename:	SOLTAMOX
Applicant:	Mayne Pharma Commrcl
Ingredient:	tamoxifen citrate
Patents:	0

Pharmacology for NDA: 021807

Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for 021807

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

Suppliers and Packaging for NDA: 021807

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807	NDA	Mayne Pharma	51862-682	51862-682-00	1 CONTAINER in 1 CARTON (51862-682-00) / 150 mL in 1 CONTAINER
SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807	NDA	Mayne Pharma	51862-682	51862-682-01	1 CONTAINER in 1 CARTON (51862-682-01) / 150 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/10ML
Approval Date:	Oct 29, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021807

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807-001	Oct 29, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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