Details for New Drug Application (NDA): 201964
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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 |
Ingredient: | felodipine |
Patents: | 0 |
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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