DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 020531
The generic ingredient in METROCREAM is metronidazole. There are eighteen drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 020531
Tradename: | METROCREAM |
Applicant: | Galderma Labs Lp |
Ingredient: | metronidazole |
Patents: | 0 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020531
Ingredient-type | Nitroimidazoles |
Medical Subject Heading (MeSH) Categories for 020531
Suppliers and Packaging for NDA: 020531
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METROCREAM | metronidazole | CREAM;TOPICAL | 020531 | NDA | Galderma Laboratories, L.P. | 0299-3836 | N | 0299-3836-45 |
METROCREAM | metronidazole | CREAM;TOPICAL | 020531 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-960 | N | 66993-960-45 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.75% | ||||
Approval Date: | Sep 20, 1995 | TE: | AB | RLD: | Yes |
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