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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 seven 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. Seventy-eight suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for NDA: 020208

Tradename:
METROGEL-VAGINAL
Applicant:
Medicis
Ingredient:
metronidazole
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 AUTHORIZED GENERIC A-S Medication Solutions 50090-2126 50090-2126-0 70 g in 1 TUBE, WITH APPLICATOR (50090-2126-0)

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 19924,837,378► subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 19925,840,744► subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 19925,536,743► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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