Details for New Drug Application (NDA): 021806
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The generic ingredient in VANDAZOLE 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 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 | RPK Pharmaceuticals, Inc. | 53002-7341 | 53002-7341-1 | 1 TUBE, WITH APPLICATOR in 1 CARTON (53002-7341-1) / 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: | ⤷ Try a Trial | Patent Expiration: | Sep 22, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
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