0480-3685-01 |
0480-3685 |
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 |
20231010 |
N/A |
ANDA |
ANDA210876 |
Teva Pharmaceuticals, Inc. |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
9.375 mg/1; 9.375 mg/1; 9.375 mg/1; 9.375 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3685-01) |
0480-3686-01 |
0480-3686 |
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 |
20231010 |
N/A |
ANDA |
ANDA210876 |
Teva Pharmaceuticals, Inc. |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
12.5 mg/1; 12.5 mg/1; 12.5 mg/1; 12.5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3686-01) |
0480-3684-01 |
0480-3684 |
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 |
20231010 |
N/A |
ANDA |
ANDA210876 |
Teva Pharmaceuticals, Inc. |
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 (0480-3684-01) |
0480-3683-01 |
0480-3683 |
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 |
20231010 |
N/A |
ANDA |
ANDA210876 |
Teva Pharmaceuticals, Inc. |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
3.125 mg/1; 3.125 mg/1; 3.125 mg/1; 3.125 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3683-01) |