Details for New Drug Application (NDA): 202540
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NDA 202540 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, Quagen, Rising, Rk Pharma, 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-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.
Suppliers and Packaging for NDA: 202540
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| URSODIOL | ursodiol | TABLET;ORAL | 202540 | ANDA | Major Pharmaceuticals | 0904-6890 | 0904-6890-04 | 30 BLISTER PACK in 1 CARTON (0904-6890-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| URSODIOL | ursodiol | TABLET;ORAL | 202540 | ANDA | AvKARE | 42291-931 | 42291-931-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Feb 14, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Feb 14, 2013 | TE: | AB | RLD: | No | ||||
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