Details for New Drug Application (NDA): 210707
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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.
Suppliers and Packaging for NDA: 210707
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | CAPSULE;ORAL | 210707 | ANDA | KVK-Tech, Inc. | 10702-237 | 10702-237-01 | 100 CAPSULE in 1 BOTTLE (10702-237-01) |
URSODIOL | ursodiol | CAPSULE;ORAL | 210707 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-871 | 43063-871-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | May 17, 2018 | TE: | AB | RLD: | No |
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