Details for New Drug Application (NDA): 214849
NDA 214849 describes URSODIOL, which is a drug marketed by Abhai Llc, Adaptis, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma, Impax Labs Inc, Lannett Co Inc, Lgm Pharma, Pharmazone, Quagen, Rising, Strides Pharma, Teva Pharms, Zydus Lifesciences, Epic Pharma Llc, Glenmark Pharms Ltd, Ph Health, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from twenty-eight suppliers. Additional details are available on the URSODIOL profile page.
The generic ingredient in URSODIOL is ursodiol. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
The generic ingredient in URSODIOL is ursodiol. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 214849
| Tradename: | URSODIOL |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | ursodiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214849
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| URSODIOL | ursodiol | CAPSULE;ORAL | 214849 | ANDA | Aurobindo Pharma Limited | 59651-421 | 59651-421-01 | 100 CAPSULE in 1 BOTTLE (59651-421-01) |
| URSODIOL | ursodiol | CAPSULE;ORAL | 214849 | ANDA | Bryant Ranch Prepack | 72162-2619 | 72162-2619-1 | 100 CAPSULE in 1 BOTTLE (72162-2619-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Nov 28, 2022 | TE: | AB | RLD: | No | ||||
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