Details for New Drug Application (NDA): 019594
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NDA 019594 describes ACTIGALL, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. Additional details are available on the ACTIGALL profile page.
The generic ingredient in ACTIGALL 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 ACTIGALL 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 019594
| Tradename: | ACTIGALL |
| Applicant: | Teva Branded Pharm |
| Ingredient: | ursodiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019594
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACTIGALL | ursodiol | CAPSULE;ORAL | 019594 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0591-3159 | 0591-3159-01 | 100 CAPSULE in 1 BOTTLE (0591-3159-01) |
| ACTIGALL | ursodiol | CAPSULE;ORAL | 019594 | NDA AUTHORIZED GENERIC | AvKARE | 42291-923 | 42291-923-01 | 100 CAPSULE in 1 BOTTLE (42291-923-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 31, 1987 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Dec 31, 1987 | TE: | AB | RLD: | Yes | ||||
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