Details for New Drug Application (NDA): 200815
✉ Email this page to a colleague
NDA 200815 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Endo Operations, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt, Yiling, and Yung Shin Pharm, and is included in thirteen NDAs. It is available from fifteen suppliers. Additional details are available on the FELODIPINE profile page.
The generic ingredient in FELODIPINE is felodipine. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
The generic ingredient in FELODIPINE is felodipine. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 200815
| Tradename: | FELODIPINE |
| Applicant: | Endo Operations |
| 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 | Endo USA, Inc. | 0603-3581 | 0603-3581-21 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3581-21) |
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815 | ANDA | Endo USA, Inc. | 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
