Details for New Drug Application (NDA): 019594
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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 | ||||
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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