Details for New Drug Application (NDA): 020901
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NDA 020901 describes METROLOTION, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from two suppliers. Additional details are available on the METROLOTION profile page.
The generic ingredient in METROLOTION is metronidazole. There are eighteen drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
The generic ingredient in METROLOTION is metronidazole. There are eighteen drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 020901
| Tradename: | METROLOTION |
| Applicant: | Galderma Labs Lp |
| Ingredient: | metronidazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020901
Suppliers and Packaging for NDA: 020901
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METROLOTION | metronidazole | LOTION;TOPICAL | 020901 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-961 | 66993-961-59 | 1 BOTTLE in 1 CARTON (66993-961-59) / 59.7 g in 1 BOTTLE |
| METROLOTION | metronidazole | LOTION;TOPICAL | 020901 | NDA AUTHORIZED GENERIC | Mayne Pharma Inc. | 68308-712 | 68308-712-59 | 1 BOTTLE in 1 CARTON (68308-712-59) / 59.7 g in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.75% | ||||
| Approval Date: | Nov 24, 1998 | TE: | AB | RLD: | Yes | ||||
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