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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Fish and Richardson
Boehringer Ingelheim
US Army
Mallinckrodt
Daiichi Sankyo
Healthtrust
AstraZeneca
Argus Health

Generated: August 20, 2017

DrugPatentWatch Database Preview

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 six 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. Eighty-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for NDA: 020208

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 020208

Ingredient-typeNitroimidazoles

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 Physicians Total Care, Inc. 54868-3110 54868-3110-0 1 TUBE, WITH APPLICATOR in 1 CARTON (54868-3110-0) > 70 g in 1 TUBE, WITH APPLICATOR

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020208

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Chubb
Chinese Patent Office
US Department of Justice
QuintilesIMS
Medtronic
Colorcon
Julphar
Mallinckrodt

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