| 35573-467-02 |
35573-467 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20191216 |
20280229 |
ANDA |
ANDA212037 |
Burel Pharmaceuticals, LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
5 mg/1; 5 mg/1; 5 mg/1; 5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-467-02) |
| 35573-468-02 |
35573-468 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20191216 |
20280229 |
ANDA |
ANDA212037 |
Burel Pharmaceuticals, LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
6.25 mg/1; 6.25 mg/1; 6.25 mg/1; 6.25 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-468-02) |
| 35573-469-02 |
35573-469 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20191216 |
20280229 |
ANDA |
ANDA212037 |
Burel Pharmaceuticals, LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
7.5 mg/1; 7.5 mg/1; 7.5 mg/1; 7.5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-469-02) |