Details for New Drug Application (NDA): 202644
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NDA 202644 describes NIFEDIPINE, which is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Leading, Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Mylan, Novast Labs, Osmotica Pharm Us, Par Pharm, Rising, Spil, Twi Pharms, Valeant Pharms North, Vitruvias, and Zydus Pharms, and is included in thirty NDAs. It is available from thirty-four 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 202644
| Tradename: | NIFEDIPINE |
| Applicant: | Heritage Pharma |
| Ingredient: | nifedipine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202644
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 202644
Suppliers and Packaging for NDA: 202644
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIFEDIPINE | nifedipine | CAPSULE;ORAL | 202644 | ANDA | Major Pharmaceuticals | 0904-7229 | 0904-7229-61 | 100 BLISTER PACK in 1 CARTON (0904-7229-61) / 1 CAPSULE in 1 BLISTER PACK |
| NIFEDIPINE | nifedipine | CAPSULE;ORAL | 202644 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-194 | 23155-194-01 | 100 CAPSULE in 1 BOTTLE (23155-194-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 25, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 25, 2013 | TE: | AB | RLD: | No | ||||
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