Details for New Drug Application (NDA): 216606
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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 216606
Tradename: | NISOLDIPINE |
Applicant: | Amta |
Ingredient: | nisoldipine |
Patents: | 0 |
Pharmacology for NDA: 216606
Mechanism of Action | Calcium Channel Antagonists |
Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 216606
Suppliers and Packaging for NDA: 216606
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 216606 | ANDA | Utopic Pharmaceuticals Inc | 84063-001 | 84063-001-04 | 1 BOTTLE in 1 CARTON (84063-001-04) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8.5MG | ||||
Approval Date: | Apr 10, 2023 | TE: | RLD: | No |
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