Details for New Drug Application (NDA): 216896
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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 216896
Tradename: | NIFEDIPINE |
Applicant: | Alembic |
Ingredient: | nifedipine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216896
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 216896
Suppliers and Packaging for NDA: 216896
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 216896 | ANDA | Alembic Pharmaceuticals Limited | 46708-732 | 46708-732-31 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-732-31) |
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 216896 | ANDA | Alembic Pharmaceuticals Limited | 46708-732 | 46708-732-63 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-732-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Nov 18, 2022 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Nov 18, 2022 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 90MG | ||||
Approval Date: | Nov 18, 2022 | TE: | AB2 | RLD: | No |
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