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Details for New Drug Application (NDA): 021806
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NDA 021806 describes VANDAZOLE, which is a drug marketed by Teva Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the VANDAZOLE profile page.
The generic ingredient in VANDAZOLE is metronidazole. There are eighteen drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
The generic ingredient in VANDAZOLE is metronidazole. There are eighteen drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 021806
| Tradename: | VANDAZOLE |
| Applicant: | Teva Pharms |
| Ingredient: | metronidazole |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANDAZOLE | metronidazole | GEL;VAGINAL | 021806 | NDA | Upsher-Smith Laboratories, LLC | 0245-0860 | 0245-0860-70 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) > 70 g in 1 TUBE, WITH APPLICATOR |
| VANDAZOLE | metronidazole | GEL;VAGINAL | 021806 | NDA | REMEDYREPACK INC. | 70518-2400 | 70518-2400-0 | 1 TUBE, WITH APPLICATOR in 1 CARTON (70518-2400-0) > 70 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;VAGINAL | Strength | 0.75% | ||||
| Approval Date: | May 20, 2005 | TE: | BX | RLD: | No | ||||
| Patent: | Start Trial | Patent Expiration: | Sep 22, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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