Details for New Drug Application (NDA): 075896
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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 075896
Tradename: | FELODIPINE |
Applicant: | Sun Pharm Industries |
Ingredient: | felodipine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075896
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 075896
Suppliers and Packaging for NDA: 075896
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 075896 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-368 | 53489-368-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-01) |
FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 075896 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-368 | 53489-368-03 | 250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
Approval Date: | Nov 2, 2004 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 2, 2004 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 2, 2004 | TE: | RLD: | No |
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