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Last Updated: January 16, 2021

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Details for New Drug Application (NDA): 020208

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NDA 020208 describes METROGEL-VAGINAL, which is a drug marketed by Bausch and is included in one NDA. Additional details are available on the METROGEL-VAGINAL profile page.

The generic ingredient in METROGEL-VAGINAL is metronidazole. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole profile page.
Summary for 020208
Tradename:METROGEL-VAGINAL
Applicant:Bausch
Ingredient:metronidazole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020208
Paragraph IV (Patent) Challenges for 020208
Tradename Dosage Ingredient NDA Submissiondate
METROGEL-VAGINAL GEL;VAGINAL metronidazole 020208 2004-09-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength0.75%
Approval Date:Aug 17, 1992TE:ABRLD:Yes

Expired US Patents for NDA 020208

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992   Start Trial   Start Trial
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992   Start Trial   Start Trial
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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