Details for New Drug Application (NDA): 205566
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The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 205566
Tradename: | FENOFIBRATE (MICRONIZED) |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205566
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 205566 | ANDA | A-S Medication Solutions | 50090-6120 | 50090-6120-0 | 90 CAPSULE in 1 BOTTLE (50090-6120-0) |
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 205566 | ANDA | American Health Packaging | 60687-713 | 60687-713-21 | 30 BLISTER PACK in 1 CARTON (60687-713-21) / 1 CAPSULE in 1 BLISTER PACK (60687-713-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 67MG | ||||
Approval Date: | Apr 7, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 134MG | ||||
Approval Date: | Apr 7, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Apr 7, 2017 | TE: | AB | RLD: | No |
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