Details for New Drug Application (NDA): 077317
✉ Email this page to a colleague
The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 077317
Tradename: | ISRADIPINE |
Applicant: | Watson Labs Teva |
Ingredient: | isradipine |
Patents: | 0 |
Pharmacology for NDA: 077317
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 077317
Suppliers and Packaging for NDA: 077317
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISRADIPINE | isradipine | CAPSULE;ORAL | 077317 | ANDA | Actavis Pharma, Inc. | 16252-539 | 16252-539-01 | 100 CAPSULE in 1 BOTTLE (16252-539-01) |
ISRADIPINE | isradipine | CAPSULE;ORAL | 077317 | ANDA | Actavis Pharma, Inc. | 16252-540 | 16252-540-01 | 100 CAPSULE in 1 BOTTLE (16252-540-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jan 5, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 5, 2006 | TE: | AB | RLD: | No |
Complete Access Available with Subscription