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Generated: November 14, 2018

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Details for New Drug Application (NDA): 021789

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NDA 021789 describes METROGEL, which is a drug marketed by Galderma Labs Lp and Medicis and is included in three NDAs. It is available from four suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the METROGEL profile page.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Ninety suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 021789
Tradename:METROGEL
Applicant:Galderma Labs Lp
Ingredient:metronidazole
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021789
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 021789
Suppliers and Packaging for NDA: 021789
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METROGEL metronidazole GEL;TOPICAL 021789 NDA Galderma Laboratories, L.P. 0299-3820 0299-3820-00 3 g in 1 BLISTER PACK (0299-3820-00)
METROGEL metronidazole GEL;TOPICAL 021789 NDA Galderma Laboratories, L.P. 0299-3820 0299-3820-01 55 g in 1 BOTTLE, PUMP (0299-3820-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Jun 30, 2005TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 21, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
Patent:➤ Sign UpPatent Expiration:Feb 21, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA

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