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

Summary for NDA: 021789

Tradename:
METROGEL
Applicant:
Galderma Labs Lp
Ingredient:
metronidazole
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021789

Ingredient-typeNitroimidazoles

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Jun 30, 2005TE:ABRLD:Yes
Patent:6,881,726Patent Expiration:Feb 21, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
Patent:7,348,317Patent 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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