Details for New Drug Application (NDA): 020531
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The generic ingredient in METROCREAM is metronidazole. There are eighteen drug master file entries for this compound. Seventy 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 |
Formulation / Manufacturing: | see details |
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 | 0299-3836-45 | 1 TUBE in 1 CARTON (0299-3836-45) / 45 g in 1 TUBE |
METROCREAM | metronidazole | CREAM;TOPICAL | 020531 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-960 | 66993-960-45 | 1 TUBE in 1 CARTON (66993-960-45) / 45 g in 1 TUBE |
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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