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. Eighteen 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 | MSN LABORATORIES PRIVATE LIMITED | 69539-151 | 69539-151-08 | 2 TABLET in 1 BOTTLE (69539-151-08) |
ALBENDAZOLE | albendazole | TABLET;ORAL | 213435 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-151 | 69539-151-28 | 28 TABLET in 1 BOTTLE (69539-151-28) |
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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