Details for New Drug Application (NDA): 203417
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NDA 203417 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 203417
| Tradename: | FELODIPINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | felodipine |
| Patents: | 0 |
Pharmacology for NDA: 203417
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 203417
Suppliers and Packaging for NDA: 203417
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 203417 | ANDA | A-S Medication Solutions | 50090-5870 | 50090-5870-0 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5870-0) |
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 203417 | ANDA | Rising Pharma Holdings, Inc. | 57237-108 | 57237-108-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-108-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jan 17, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 17, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 17, 2013 | TE: | AB | RLD: | No | ||||
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