Details for New Drug Application (NDA): 211034
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NDA 211034 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 fifteen 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the albendazole profile page.
Summary for 211034
| Tradename: | ALBENDAZOLE |
| Applicant: | Dr Reddys |
| Ingredient: | albendazole |
| Patents: | 0 |
Pharmacology for NDA: 211034
| Mechanism of Action | Cytochrome P450 1A Inducers |
Medical Subject Heading (MeSH) Categories for 211034
Suppliers and Packaging for NDA: 211034
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALBENDAZOLE | albendazole | TABLET;ORAL | 211034 | ANDA | Dr.Reddys Laboratories Inc | 43598-452 | 43598-452-02 | 2 TABLET, FILM COATED in 1 BOTTLE (43598-452-02) |
| ALBENDAZOLE | albendazole | TABLET;ORAL | 211034 | ANDA | Dr.Reddys Laboratories Inc | 43598-452 | 43598-452-17 | 1 BLISTER PACK in 1 CARTON (43598-452-17) / 8 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 26, 2021 | TE: | AB | RLD: | No | ||||
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