Details for New Drug Application (NDA): 211145
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NDA 211145 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-eight 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. Thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 211145
| Tradename: | URSODIOL |
| Applicant: | Zydus Lifesciences |
| Ingredient: | ursodiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211145
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| URSODIOL | ursodiol | TABLET;ORAL | 211145 | ANDA | American Health Packaging | 60687-527 | 60687-527-21 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11) |
| URSODIOL | ursodiol | TABLET;ORAL | 211145 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1127 | 70710-1127-1 | 100 TABLET in 1 BOTTLE (70710-1127-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Oct 30, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Oct 30, 2018 | TE: | AB | RLD: | No | ||||
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