Details for New Drug Application (NDA): 213555
NDA 213555 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 213555
| Tradename: | URSODIOL |
| Applicant: | Chartwell Rx |
| Ingredient: | ursodiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213555
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| URSODIOL | ursodiol | CAPSULE;ORAL | 213555 | ANDA | Chartwell RX, LLC | 62135-430 | 62135-430-60 | 60 CAPSULE in 1 BOTTLE (62135-430-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 17, 2020 | TE: | AB | RLD: | No | ||||
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