Details for New Drug Application (NDA): 213361
✉ Email this page to a colleague
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 213361
Tradename: | NIFEDIPINE |
Applicant: | Aurobindo Pharma |
Ingredient: | nifedipine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213361
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 213361
Suppliers and Packaging for NDA: 213361
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 213361 | ANDA | Aurobindo Pharma Limited | 59651-295 | 59651-295-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-295-01) |
NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 213361 | ANDA | Aurobindo Pharma Limited | 59651-296 | 59651-296-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-296-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Jul 19, 2021 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
Approval Date: | Jul 19, 2021 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 90MG | ||||
Approval Date: | Jul 19, 2021 | TE: | AB1 | RLD: | No |
Complete Access Available with Subscription