Details for New Drug Application (NDA): 213361
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NDA 213361 describes NIFEDIPINE, which is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Teva, Velzen Pharma Pvt, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Novast Labs, Osmotica Pharm Us, Ph Health, Pharmadax, Pharmobedient, Rising, Spil, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in thirty NDAs. It is available from thirty-three suppliers. Additional details are available on the NIFEDIPINE profile page.
The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-four 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 |
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 | ||||
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