Details for New Drug Application (NDA): 090788
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NDA 090788 describes DIDANOSINE, which is a drug marketed by Aurobindo Pharma, Barr, Norvium Bioscience, and Aurobindo, and is included in five NDAs. Additional details are available on the DIDANOSINE profile page.
The generic ingredient in DIDANOSINE is didanosine. There are eight drug master file entries for this compound. Additional details are available on the didanosine profile page.
The generic ingredient in DIDANOSINE is didanosine. There are eight drug master file entries for this compound. Additional details are available on the didanosine profile page.
Summary for 090788
| Tradename: | DIDANOSINE |
| Applicant: | Norvium Bioscience |
| Ingredient: | didanosine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 090788
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 125MG | ||||
| Approval Date: | Apr 8, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 200MG | ||||
| Approval Date: | Apr 8, 2010 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 250MG | ||||
| Approval Date: | Apr 8, 2010 | TE: | RLD: | No | |||||
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