Details for New Drug Application (NDA): 079082
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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 079082
Tradename: | URSODIOL |
Applicant: | Lannett Co Inc |
Ingredient: | ursodiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 079082
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | CAPSULE;ORAL | 079082 | ANDA | Lannett Company, Inc. | 0527-1326 | 0527-1326-01 | 100 CAPSULE in 1 BOTTLE (0527-1326-01) |
URSODIOL | ursodiol | CAPSULE;ORAL | 079082 | ANDA | American Health Packaging | 60687-100 | 60687-100-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-100-01) / 1 CAPSULE in 1 BLISTER PACK (60687-100-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Dec 15, 2008 | TE: | AB | RLD: | No |
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