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Last Updated: May 21, 2022

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. It is available from two 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. Sixty-four suppliers are listed 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
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 NuCare Pharmaceuticals,Inc. 68071-1753 68071-1753-7 70 g in 1 BOX (68071-1753-7)
METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-455 68682-455-70 70 g in 1 TUBE, WITH APPLICATOR (68682-455-70)

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

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