Details for New Drug Application (NDA): 211301
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NDA 211301 describes URSODIOL, which is a drug marketed by Abhai Llc, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Hibrow Hlthcare, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Norvium Bioscience, Rising, Rk Pharma, Strides Pharma, Teva Pharms, Zydus Lifesciences, Endo Operations, Epic Pharma Llc, Glenmark Pharms Ltd, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from twenty-seven suppliers. Additional details are available on the URSODIOL profile page.
The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 211301
| Tradename: | URSODIOL |
| Applicant: | Amneal Pharms Co |
| Ingredient: | ursodiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211301
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| URSODIOL | ursodiol | CAPSULE;ORAL | 211301 | ANDA | Major Pharmaceuticals | 0904-7168 | 0904-7168-06 | 50 BLISTER PACK in 1 CARTON (0904-7168-06) / 1 CAPSULE in 1 BLISTER PACK |
| URSODIOL | ursodiol | CAPSULE;ORAL | 211301 | ANDA | Major Pharmaceuticals | 0904-7168 | 0904-7168-61 | 100 BLISTER PACK in 1 CARTON (0904-7168-61) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Oct 16, 2018 | TE: | AB | RLD: | No | ||||
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