Details for New Drug Application (NDA): 210705
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NDA 210705 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, Invagen Pharms, Novast Labs, Pharmobedient, 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-six 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-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 210705
| Tradename: | FENOFIBRATE (MICRONIZED) |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | fenofibrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210705
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210705 | ANDA | Ajanta Pharma USA Inc. | 27241-118 | 27241-118-04 | 100 CAPSULE in 1 BOTTLE (27241-118-04) |
| FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210705 | ANDA | Ajanta Pharma USA Inc. | 27241-118 | 27241-118-05 | 500 CAPSULE in 1 BOTTLE (27241-118-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 67MG | ||||
| Approval Date: | Sep 10, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 134MG | ||||
| Approval Date: | Sep 10, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 10, 2018 | TE: | AB | RLD: | No | ||||
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