Details for New Drug Application (NDA): 090859
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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 090859
Tradename: | FENOFIBRATE (MICRONIZED) |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090859
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 090859 | ANDA | Dr. Reddy's Laboratories Limited | 55111-349 | 55111-349-01 | 100 CAPSULE in 1 BOTTLE (55111-349-01) |
FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 090859 | ANDA | Dr. Reddy's Laboratories Limited | 55111-349 | 55111-349-30 | 30 CAPSULE in 1 BOTTLE (55111-349-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 43MG | ||||
Approval Date: | Mar 1, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 130MG | ||||
Approval Date: | Mar 1, 2012 | TE: | AB | RLD: | No |
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