Details for New Drug Application (NDA): 202252
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The generic ingredient in FENOFIBRATE (MICRONIZED) 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 202252
Tradename: | FENOFIBRATE (MICRONIZED) |
Applicant: | Apotex |
Ingredient: | fenofibrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 202252
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 202252 | ANDA | Apotex Corp. | 60505-3120 | 60505-3120-1 | 100 CAPSULE in 1 BOTTLE (60505-3120-1) |
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 202252 | ANDA | Apotex Corp. | 60505-3120 | 60505-3120-3 | 30 CAPSULE in 1 BOTTLE (60505-3120-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 43MG | ||||
Approval Date: | Jul 26, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 130MG | ||||
Approval Date: | Jul 26, 2013 | TE: | AB | RLD: | No |
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