Application 206735
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 003 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1070 | Dextroamphetamine Sulfate | Dextroamphetamine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1071 | Dextroamphetamine Sulfate | Dextroamphetamine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1072 | Dextroamphetamine Sulfate | Dextroamphetamine | Mylan Pharmaceuticals Inc. | ANDA | Current |