Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

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 Bausch and is included in three NDAs. It is available from two 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-five 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
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)
Paragraph IV (Patent) Challenges for 021789
Tradename Dosage Ingredient NDA Submissiondate
METROGEL GEL;TOPICAL metronidazole 021789 2008-10-21

Profile for product number 001

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