Details for New Drug Application (NDA): 201067
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NDA 201067 describes ISRADIPINE, which is a drug marketed by Elite Labs Inc, Watson Labs Teva, and Norvium Bioscience, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ISRADIPINE profile page.
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.
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 201067
| Tradename: | ISRADIPINE |
| Applicant: | Norvium Bioscience |
| Ingredient: | isradipine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 201067
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 27, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 27, 2015 | TE: | RLD: | No | |||||
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