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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

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. Fifty-nine suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 021806
Applicant:Teva Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 021806
Medical Subject Heading (MeSH) Categories for 021806
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 REMEDYREPACK INC. 70518-2400 70518-2400-0 1 TUBE, WITH APPLICATOR in 1 CARTON (70518-2400-0) > 70 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength0.75%
Approval Date:May 20, 2005TE:BXRLD:No
Patent:  Start TrialPatent Expiration:Sep 22, 2024Product Flag?YSubstance Flag?Delist Request?

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