Details for New Drug Application (NDA): 075269
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The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 075269
Tradename: | NIFEDIPINE |
Applicant: | Valeant Pharms North |
Ingredient: | nifedipine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075269
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 075269
Suppliers and Packaging for NDA: 075269
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 075269 | ANDA | A-S Medication Solutions | 50090-4234 | 50090-4234-0 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4234-0) |
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 075269 | ANDA | A-S Medication Solutions | 50090-4234 | 50090-4234-2 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4234-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Dec 4, 2000 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Dec 4, 2000 | TE: | AB1 | RLD: | No |
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