Details for New Drug Application (NDA): 075289
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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 075289
Tradename: | NIFEDIPINE |
Applicant: | Valeant Pharms North |
Ingredient: | nifedipine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075289
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 075289
Suppliers and Packaging for NDA: 075289
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 075289 | ANDA | Oceanside Pharmaceuticals | 68682-108 | 68682-108-10 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-108-10) |
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 075289 | ANDA | Oceanside Pharmaceuticals | 68682-108 | 68682-108-30 | 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-108-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Sep 27, 2000 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Feb 6, 2001 | TE: | AB2 | RLD: | No |
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