Details for New Drug Application (NDA): 020901
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The generic ingredient in METROLOTION 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 020901
Tradename: | METROLOTION |
Applicant: | Galderma Labs Lp |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | Galderma Laboratories, L.P. | 0299-3838 | 0299-3838-02 | 1 BOTTLE, PLASTIC in 1 CARTON (0299-3838-02) / 59 mL in 1 BOTTLE, PLASTIC |
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 |
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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