Details for New Drug Application (NDA): 213435
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The generic ingredient in ALBENDAZOLE is albendazole. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the albendazole profile page.
Summary for 213435
| Tradename: | ALBENDAZOLE |
| Applicant: | Msn |
| Ingredient: | albendazole |
| Patents: | 0 |
Pharmacology for NDA: 213435
| Mechanism of Action | Cytochrome P450 1A Inducers |
Medical Subject Heading (MeSH) Categories for 213435
Suppliers and Packaging for NDA: 213435
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALBENDAZOLE | albendazole | TABLET;ORAL | 213435 | ANDA | Bryant Ranch Prepack | 72162-2359 | 72162-2359-2 | 2 TABLET in 1 BOTTLE (72162-2359-2) |
| ALBENDAZOLE | albendazole | TABLET;ORAL | 213435 | ANDA | Novadoz Pharmaceuticals LLC | 72205-051 | 72205-051-08 | 2 TABLET in 1 BOTTLE (72205-051-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 21, 2021 | TE: | AB | RLD: | No | ||||
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