Details for New Drug Application (NDA): 077275
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NDA 077275 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 077275
| Tradename: | DIDANOSINE |
| Applicant: | Aurobindo |
| Ingredient: | didanosine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 077275
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 14, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 150MG | ||||
| Approval Date: | Aug 14, 2012 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 14, 2012 | TE: | RLD: | No | |||||
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