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Generated: April 21, 2019

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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 Medicis and is included in one NDA. It is available from five suppliers. 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. Ninety-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 020208
Tradename:METROGEL-VAGINAL
Applicant:Medicis
Ingredient:metronidazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020208
Medical Subject Heading (MeSH) Categories for 020208
Suppliers and Packaging for NDA: 020208
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208 NDA AUTHORIZED GENERIC Aidarex Pharmaceuticals LLC 33261-786 33261-786-01 70 g in 1 TUBE, WITH APPLICATOR (33261-786-01)
METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-2126 50090-2126-0 70 g in 1 TUBE, WITH APPLICATOR (50090-2126-0)

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
Medicis METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Medicis METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Medicis METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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