Details for New Drug Application (NDA): 091001
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NDA 091001 describes NISOLDIPINE, which is a drug marketed by Amta and Mylan and is included in three NDAs. 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. Two 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. Two 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 |
Medical Subject Heading (MeSH) Categories for 091001
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 | |||||
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