Details for New Drug Application (NDA): 021806

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NDA 021806 describes VANDAZOLE, which is a drug marketed by Teva Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the VANDAZOLE profile page.

The generic ingredient in VANDAZOLE is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for 021806

Tradename:	VANDAZOLE
Applicant:	Teva Pharms
Ingredient:	metronidazole
Patents:	1

Pharmacology for NDA: 021806

Medical Subject Heading (MeSH) Categories for 021806

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 021806

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VANDAZOLE	metronidazole	GEL;VAGINAL	021806	NDA	Upsher-Smith Laboratories, LLC	0245-0860	0245-0860-70	1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR
VANDAZOLE	metronidazole	GEL;VAGINAL	021806	NDA	RPK Pharmaceuticals, Inc.	53002-7341	53002-7341-1	1 TUBE, WITH APPLICATOR in 1 CARTON (53002-7341-1) / 70 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;VAGINAL			Strength	0.75%
Approval Date:	May 20, 2005	TE:	BX	RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Sep 22, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021806

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms	VANDAZOLE	metronidazole	GEL;VAGINAL	021806-001	May 20, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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