Details for New Drug Application (NDA): 020334
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NDA 020334 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 020334
| Tradename: | FLAGYL |
| Applicant: | Pfizer |
| Ingredient: | metronidazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020334
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLAGYL | metronidazole | CAPSULE;ORAL | 020334 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-1942 | 0025-1942-34 | 100 BLISTER PACK in 1 CARTON (0025-1942-34) / 1 CAPSULE in 1 BLISTER PACK |
| FLAGYL | metronidazole | CAPSULE;ORAL | 020334 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-1942 | 0025-1942-50 | 50 CAPSULE in 1 BOTTLE (0025-1942-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 375MG | ||||
| Approval Date: | May 3, 1995 | TE: | AB | RLD: | Yes | ||||
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