Details for New Drug Application (NDA): 090365
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NDA 090365 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Ph Health, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt Bio Ag, Yiling, 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 are seventeen drug master file entries 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 are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 090365
| Tradename: | FELODIPINE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | felodipine |
| Patents: | 0 |
Pharmacology for NDA: 090365
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 090365
Suppliers and Packaging for NDA: 090365
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 090365 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-233 | 68462-233-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-233-01) |
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 090365 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-233 | 68462-233-10 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-233-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Dec 17, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 17, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 17, 2010 | TE: | AB | RLD: | No | ||||
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