Details for New Drug Application (NDA): 208979
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The generic ingredient in ALBENDAZOLE is albendazole. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the albendazole profile page.
Summary for 208979
Tradename: | ALBENDAZOLE |
Applicant: | Zydus Pharms |
Ingredient: | albendazole |
Patents: | 0 |
Pharmacology for NDA: 208979
Mechanism of Action | Cytochrome P450 1A Inducers |
Medical Subject Heading (MeSH) Categories for 208979
Suppliers and Packaging for NDA: 208979
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBENDAZOLE | albendazole | TABLET;ORAL | 208979 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1021 | 70710-1021-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1021-1) |
ALBENDAZOLE | albendazole | TABLET;ORAL | 208979 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1021 | 70710-1021-3 | 1 BLISTER PACK in 1 CARTON (70710-1021-3) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Dec 14, 2018 | TE: | AB | RLD: | No |
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