Details for New Drug Application (NDA): 211117
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NDA 211117 describes ALBENDAZOLE, which is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Cipla Ltd, Dr Reddys, Edenbridge Pharms, MSN, Strides Pharma, and Zydus Pharms, and is included in nine NDAs. It is available from sixteen suppliers. Additional details are available on the ALBENDAZOLE profile page.
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.
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 211117
| Tradename: | ALBENDAZOLE |
| Applicant: | Edenbridge Pharms |
| Ingredient: | albendazole |
| Patents: | 0 |
Pharmacology for NDA: 211117
| Mechanism of Action | Cytochrome P450 1A Inducers |
Medical Subject Heading (MeSH) Categories for 211117
Suppliers and Packaging for NDA: 211117
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALBENDAZOLE | albendazole | TABLET;ORAL | 211117 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-110 | 42799-110-02 | 2 TABLET in 1 BOTTLE (42799-110-02) |
| ALBENDAZOLE | albendazole | TABLET;ORAL | 211117 | ANDA | Golden State Medical Supply | 51407-258 | 51407-258-02 | 2 TABLET in 1 BOTTLE (51407-258-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 14, 2019 | TE: | AB | RLD: | No | ||||
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