Details for New Drug Application (NDA): 075517
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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.
Summary for 075517
Tradename: | URSODIOL |
Applicant: | Epic Pharma |
Ingredient: | ursodiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075517
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | CAPSULE;ORAL | 075517 | ANDA | PuraCap Laboratories, LLC | 24658-780 | 24658-780-01 | 100 CAPSULE in 1 BOTTLE (24658-780-01) |
URSODIOL | ursodiol | CAPSULE;ORAL | 075517 | ANDA | PuraCap Laboratories, LLC | 24658-999 | 24658-999-10 | 1000 CAPSULE in 1 BOTTLE (24658-999-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Mar 14, 2000 | TE: | AB | RLD: | No |
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