Details for New Drug Application (NDA): 201748
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The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 201748
Tradename: | FENOFIBRATE |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | fenofibrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 201748
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | CAPSULE;ORAL | 201748 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-443 | 63304-443-05 | 500 CAPSULE in 1 BOTTLE (63304-443-05) |
FENOFIBRATE | fenofibrate | CAPSULE;ORAL | 201748 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-443 | 63304-443-30 | 30 CAPSULE in 1 BOTTLE (63304-443-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 43MG | ||||
Approval Date: | Oct 31, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 130MG | ||||
Approval Date: | Oct 31, 2014 | TE: | AB | RLD: | No |
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