70010-030-01 |
70010-030 |
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 |
20230220 |
N/A |
ANDA |
ANDA217027 |
Granules Pharmaceuticals Inc. |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-030-01) |
70010-034-01 |
70010-034 |
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 |
20230220 |
N/A |
ANDA |
ANDA217027 |
Granules Pharmaceuticals Inc. |
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 (70010-034-01) |
70010-031-01 |
70010-031 |
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 |
20230220 |
N/A |
ANDA |
ANDA217027 |
Granules Pharmaceuticals Inc. |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-031-01) |
70010-032-01 |
70010-032 |
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 |
20230220 |
N/A |
ANDA |
ANDA217027 |
Granules Pharmaceuticals Inc. |
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 (70010-032-01) |
70010-029-01 |
70010-029 |
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 |
20230220 |
N/A |
ANDA |
ANDA217027 |
Granules Pharmaceuticals Inc. |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-029-01) |
70010-033-01 |
70010-033 |
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 |
20230220 |
N/A |
ANDA |
ANDA217027 |
Granules 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 (70010-033-01) |