Details for New Drug Application (NDA): 201748
NDA 201748 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Chartwell Rx, Glenmark Pharms Ltd, Impax Labs, Ingenus Pharms Llc, Invagen Pharms, Pharmobedient, Reyoung, Rhodes Pharms, Rising, Sun Pharm Inds Ltd, and Torrent, and is included in seventeen NDAs. It is available from sixteen suppliers. Additional details are available on the FENOFIBRATE (MICRONIZED) profile page.
The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There is one drug master file entry 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 is one drug master file entry for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 201748
| Tradename: | FENOFIBRATE (MICRONIZED) |
| 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 (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 201748 | ANDA | PD-Rx Pharmaceuticals, Inc. | 72789-310 | 72789-310-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-310-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 43MG | ||||
| Approval Date: | Oct 31, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 130MG | ||||
| Approval Date: | Oct 31, 2014 | TE: | RLD: | No | |||||
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