Details for New Drug Application (NDA): 210434
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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 210434
Tradename: | ALBENDAZOLE |
Applicant: | Cipla Ltd |
Ingredient: | albendazole |
Patents: | 0 |
Pharmacology for NDA: 210434
Mechanism of Action | Cytochrome P450 1A Inducers |
Medical Subject Heading (MeSH) Categories for 210434
Suppliers and Packaging for NDA: 210434
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBENDAZOLE | albendazole | TABLET;ORAL | 210434 | ANDA | Cipla USA Inc. | 69097-237 | 69097-237-72 | 2 TABLET in 1 BOTTLE (69097-237-72) |
ALBENDAZOLE | albendazole | TABLET;ORAL | 210434 | ANDA | Cipla USA Inc. | 69097-237 | 69097-237-73 | 28 TABLET in 1 BOTTLE (69097-237-73) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Sep 21, 2018 | TE: | RLD: | No |
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