Details for New Drug Application (NDA): 216606
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NDA 216606 describes NISOLDIPINE, which is a drug marketed by Amta and Mylan and is included in three NDAs. It is available from one supplier. Additional details are available on the NISOLDIPINE profile page.
The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Three 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 |
Medical Subject Heading (MeSH) Categories for 216606
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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