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Details for New Drug Application (NDA): 200750
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NDA 200750 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Aurobindo Pharma Ltd, Graviti Pharms, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, and Twi Pharms, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FENOFIBRIC ACID profile page.
The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 200750
| Tradename: | FENOFIBRIC ACID |
| Applicant: | Lupin Ltd |
| Ingredient: | choline fenofibrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 200750
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 200750 | ANDA | A-S Medication Solutions | 50090-4373 | 50090-4373-0 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4373-0) |
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 200750 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-128 | 68180-128-01 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 45MG FENOFIBRIC ACID | ||||
| Approval Date: | Dec 4, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 135MG FENOFIBRIC ACID | ||||
| Approval Date: | Dec 4, 2013 | TE: | AB | RLD: | No | ||||
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