Details for New Drug Application (NDA): 019737
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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 019737
Tradename: | METROGEL |
Applicant: | Galderma Labs Lp |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 019737
Suppliers and Packaging for NDA: 019737
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METROGEL | metronidazole | GEL;TOPICAL | 019737 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-962 | 66993-962-45 | 1 TUBE in 1 CARTON (66993-962-45) / 45 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.75% | ||||
Approval Date: | Nov 22, 1988 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 019737
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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