FdaApplication
ANDA 205077
Identifiers
- fda_app_no: ANDA205077
Properties
| Property | Value |
|---|---|
| applicant_name | STRIDES PHARMA GLOBAL PTE LTD |
| application_type | ANDA |
| approval_date | 2019-06-21 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL |
3 products