Details for New Drug Application (NDA): 012623
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NDA 012623 describes FLAGYL, which is a drug marketed by Pfizer and Baxter Hlthcare and is included in five NDAs. It is available from one supplier. Additional details are available on the FLAGYL profile page.
The generic ingredient in FLAGYL is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.
The generic ingredient in FLAGYL is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.
Summary for 012623
| Tradename: | FLAGYL |
| Applicant: | Pfizer |
| Ingredient: | metronidazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 012623
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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