Details for New Drug Application (NDA): 200815
NDA 200815 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Ph Health, Pharmobedient, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt Bio Ag, and Yung Shin Pharm, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the FELODIPINE profile page.
The generic ingredient in FELODIPINE is felodipine. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
The generic ingredient in FELODIPINE is felodipine. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 200815
| Tradename: | FELODIPINE |
| Applicant: | Ph Health |
| Ingredient: | felodipine |
| Patents: | 0 |
Pharmacology for NDA: 200815
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 200815
Suppliers and Packaging for NDA: 200815
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815 | ANDA | Par Health USA, LLC | 0603-3581 | 0603-3581-21 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3581-21) |
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815 | ANDA | Par Health USA, LLC | 0603-3581 | 0603-3581-28 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3581-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Oct 28, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 28, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 28, 2011 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
