Details for New Drug Application (NDA): 078178
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NDA 078178 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic, Chartwell Rx, Cosette, Fougera Pharms, Zydus Lifesciences, Aurobindo Pharma Ltd, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Appco, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Esjay Pharma, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, and Rising, and is included in sixty-nine NDAs. It is available from fifty-four suppliers. Additional details are available on the METRONIDAZOLE profile page.
The generic ingredient in METRONIDAZOLE 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 METRONIDAZOLE 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 078178
| Tradename: | METRONIDAZOLE |
| Applicant: | Cosette |
| Ingredient: | metronidazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078178
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | metronidazole | GEL;TOPICAL | 078178 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0637 | 0713-0637-37 | 1 TUBE in 1 CARTON (0713-0637-37) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.75% | ||||
| Approval Date: | Jan 19, 2011 | TE: | AB | RLD: | No | ||||
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