Details for New Drug Application (NDA): 216067
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The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 216067
Tradename: | NIFEDIPINE |
Applicant: | Alkem Labs Ltd |
Ingredient: | nifedipine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216067
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 216067
Suppliers and Packaging for NDA: 216067
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 216067 | ANDA | A-S Medication Solutions | 50090-6732 | 50090-6732-0 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-0) |
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 216067 | ANDA | A-S Medication Solutions | 50090-6732 | 50090-6732-1 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Mar 29, 2022 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Mar 29, 2022 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 90MG | ||||
Approval Date: | Mar 29, 2022 | TE: | AB2 | RLD: | No |
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