Details for New Drug Application (NDA): 091001
✉ Email this page to a colleague
The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 091001
Tradename: | NISOLDIPINE |
Applicant: | Mylan |
Ingredient: | nisoldipine |
Patents: | 0 |
Pharmacology for NDA: 091001
Mechanism of Action | Calcium Channel Antagonists |
Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 091001
Suppliers and Packaging for NDA: 091001
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2096 | 0378-2096-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2096-01) |
NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2097 | 0378-2097-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2097-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8.5MG | ||||
Approval Date: | Jan 26, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 17MG | ||||
Approval Date: | Jan 26, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25.5MG | ||||
Approval Date: | Jan 26, 2011 | TE: | RLD: | No |
Complete Access Available with Subscription