Details for New Drug Application (NDA): 077127
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NDA 077127 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, Endo Operations, Martec Usa Llc, Norvium Bioscience, Novast Labs, Osmotica Pharm Us, Rising, Spil, Swiss Pharm, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in thirty NDAs. It is available from thirty-five 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-six 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-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 077127
| Tradename: | NIFEDIPINE |
| Applicant: | Osmotica Pharm Us |
| Ingredient: | nifedipine |
| Patents: | 0 |
Pharmacology for NDA: 077127
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 077127
Suppliers and Packaging for NDA: 077127
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 077127 | ANDA | A-S Medication Solutions | 50090-4158 | 50090-4158-0 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4158-0) |
| NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 077127 | ANDA | A-S Medication Solutions | 50090-4158 | 50090-4158-1 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4158-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Nov 21, 2005 | TE: | AB2 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Nov 21, 2005 | TE: | AB2 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 90MG | ||||
| Approval Date: | Oct 3, 2007 | TE: | AB2 | RLD: | No | ||||
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