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Details for New Drug Application (NDA): 020531
NDA 020531 describes METROCREAM, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers. Additional details are available on the METROCREAM profile page.
The generic ingredient in METROCREAM 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.
The generic ingredient in METROCREAM 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 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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