| 72162-2058-3 |
72162-2058 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
5 mg/1; 5 mg/1; 5 mg/1; 5 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2058-3) |
| 72162-2058-6 |
72162-2058 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
5 mg/1; 5 mg/1; 5 mg/1; 5 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2058-6) |
| 72162-2058-9 |
72162-2058 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
5 mg/1; 5 mg/1; 5 mg/1; 5 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2058-9) |
| 72162-2059-1 |
72162-2059 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 (72162-2059-1) |
| 72162-2059-3 |
72162-2059 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2059-3) |
| 72162-2059-6 |
72162-2059 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2059-6) |
| 72162-2059-9 |
72162-2059 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2059-9) |
| 72162-2060-1 |
72162-2060 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 (72162-2060-1) |
| 72162-2060-3 |
72162-2060 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2060-3) |
| 72162-2060-6 |
72162-2060 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2060-6) |
| 72162-2060-9 |
72162-2060 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2060-9) |
| 64850-512-01 |
64850-512 |
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 |
N/A |
ANDA |
ANDA212037 |
Elite Laboratories, 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 (64850-512-01) |
| 64850-511-01 |
64850-511 |
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 |
N/A |
ANDA |
ANDA212037 |
Elite Laboratories, 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 (64850-511-01) |
| 64850-510-01 |
64850-510 |
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 |
N/A |
ANDA |
ANDA212037 |
Elite Laboratories, 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 (64850-510-01) |
| 72162-2055-3 |
72162-2055 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2055-3) |
| 72162-2055-6 |
72162-2055 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2055-6) |
| 72162-2055-9 |
72162-2055 |
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 |
20230614 |
N/A |
ANDA |
ANDA212037 |
Bryant Ranch Prepack |
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 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-2055-9) |
| 35573-465-02 |
35573-465 |
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 |
2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-465-02) |
| 35573-466-02 |
35573-466 |
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 |
3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02) |
| 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) |