DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077169
The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 077169
Tradename: | ISRADIPINE |
Applicant: | Elite Labs Inc |
Ingredient: | isradipine |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077169
Ingredient-type | Dihydropyridines |
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 077169
Suppliers and Packaging for NDA: 077169
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISRADIPINE | isradipine | CAPSULE;ORAL | 077169 | ANDA | Epic Pharma, LLC | 42806-263 | N | 42806-263-01 |
ISRADIPINE | isradipine | CAPSULE;ORAL | 077169 | ANDA | Epic Pharma, LLC | 42806-263 | N | 42806-263-05 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
Approval Date: | Apr 24, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 24, 2006 | TE: | AB | RLD: | No |
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