Suppliers and packages for generic ingredient: amphetamine; amphetamine aspartate/dextroamphetamine sulfate
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amphetamine; amphetamine aspartate/dextroamphetamine sulfate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Tris Pharma Inc | DYANAVEL XR | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147 | NDA | NextWave Pharmaceuticals, Inc | 24478-102-01 | 1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE | 2015-10-01 |
| Tris Pharma Inc | DYANAVEL XR 10 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | NDA | NextWave Pharmaceuticals, Inc | 24478-106-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01) | 2021-11-04 |
| Tris Pharma Inc | DYANAVEL XR 10 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | NDA | NextWave Pharmaceuticals, Inc | 24478-108-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-108-01) | 2021-11-04 |
| Tris Pharma Inc | DYANAVEL XR 10 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | NDA | NextWave Pharmaceuticals, Inc | 24478-109-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-109-01) | 2021-11-04 |
| Tris Pharma Inc | DYANAVEL XR 10 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | NDA | NextWave Pharmaceuticals, Inc | 24478-110-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-110-01) | 2021-11-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
