Application 077167
- Type
- ANDA
- Sponsor
- BARR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIDANOSINE | DIDANOSINE | CAPSULE, DELAYED REL PELLETS;ORAL | 200MG | No | No |
| 002 | DIDANOSINE | DIDANOSINE | CAPSULE, DELAYED REL PELLETS;ORAL | 250MG | No | No |
| 003 | DIDANOSINE | DIDANOSINE | CAPSULE, DELAYED REL PELLETS;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0555-0588 | Didanosine | Didanosine | Teva Pharmaceuticals USA, | ANDA | Current |
| 0555-0589 | Didanosine | Didanosine | Teva Pharmaceuticals USA, | ANDA | Current |
| 0555-0590 | Didanosine | Didanosine | Teva Pharmaceuticals USA, | ANDA | Current |
| 53808-0236 | Didanosine | Didanosine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0353 | Didanosine | Didanosine | State of Florida DOH Central Pharmacy | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9014 | ORIG | 2004-12-06 |