Details for New Drug Application (NDA): 213842
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NDA 213842 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, Rhodes Pharms, Rising, and Torrent, and is included in sixteen NDAs. It is available from seventeen suppliers. Additional details are available on the FENOFIBRATE (MICRONIZED) profile page.
The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 213842
| Tradename: | FENOFIBRATE (MICRONIZED) |
| Applicant: | Alembic |
| Ingredient: | fenofibrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213842
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 213842 | ANDA | Alembic Pharmaceuticals Limited | 46708-084 | 46708-084-30 | 30 CAPSULE in 1 BOTTLE (46708-084-30) |
| FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 213842 | ANDA | Alembic Pharmaceuticals Limited | 46708-084 | 46708-084-31 | 100 CAPSULE in 1 BOTTLE (46708-084-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 67MG | ||||
| Approval Date: | Oct 19, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 134MG | ||||
| Approval Date: | Oct 19, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Oct 19, 2020 | TE: | AB | RLD: | No | ||||
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