Details for New Drug Application (NDA): 021789
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The generic ingredient in METROGEL 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 021789
Tradename: | METROGEL |
Applicant: | Galderma Labs Lp |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021789
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METROGEL | metronidazole | GEL;TOPICAL | 021789 | NDA | Galderma Laboratories, L.P. | 0299-3820 | 0299-3820-60 | 60 g in 1 TUBE (0299-3820-60) |
METROGEL | metronidazole | GEL;TOPICAL | 021789 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-936 | 66993-936-61 | 60 g in 1 TUBE (66993-936-61) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 1% | ||||
Approval Date: | Jun 30, 2005 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021789
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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