Details for New Drug Application (NDA): 211301
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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 211301
Tradename: | URSODIOL |
Applicant: | Amneal Pharms Co |
Ingredient: | ursodiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 211301
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | CAPSULE;ORAL | 211301 | ANDA | Major Pharmaceuticals | 0904-7168 | 0904-7168-06 | 50 BLISTER PACK in 1 CARTON (0904-7168-06) / 1 CAPSULE in 1 BLISTER PACK |
URSODIOL | ursodiol | CAPSULE;ORAL | 211301 | ANDA | Major Pharmaceuticals | 0904-7168 | 0904-7168-61 | 100 BLISTER PACK in 1 CARTON (0904-7168-61) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Oct 16, 2018 | TE: | AB | RLD: | No |
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