Details for New Drug Application (NDA): 201964
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NDA 201964 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Generics, Heritage Pharms, Jubilant Generics, Mylan, Orbion Pharms, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Vintage Pharms Llc, 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 201964
| Tradename: | FELODIPINE |
| Applicant: | Heritage Pharms |
| Ingredient: | felodipine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201964
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 201964
Suppliers and Packaging for NDA: 201964
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 201964 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-048 | 23155-048-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-01) |
| FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 201964 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-048 | 23155-048-05 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Nov 8, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 8, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 8, 2013 | TE: | AB | RLD: | No | ||||
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