0781-2329-01 |
0781-2329 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270228 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Sandoz 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 (0781-2329-01) |
0781-2368-01 |
0781-2368 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270331 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Sandoz 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 (0781-2368-01) |
66993-596-02 |
66993-596 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270430 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Prasco Laboratories |
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 (66993-596-02) |
54092-381-01 |
54092-381 |
HUMAN PRESCRIPTION DRUG |
Adderall XR |
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20020522 |
N/A |
NDA |
NDA021303 |
Takeda Pharmaceuticals America, 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 (54092-381-01) |
54092-389-01 |
54092-389 |
HUMAN PRESCRIPTION DRUG |
Adderall XR |
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20020522 |
N/A |
NDA |
NDA021303 |
Takeda Pharmaceuticals America, 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 (54092-389-01) |
0781-2343-01 |
0781-2343 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270430 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Sandoz 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 (0781-2343-01) |
66993-594-02 |
66993-594 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270228 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Prasco Laboratories |
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 (66993-594-02) |
66993-598-02 |
66993-598 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270331 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Prasco Laboratories |
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 (66993-598-02) |
54092-385-01 |
54092-385 |
HUMAN PRESCRIPTION DRUG |
Adderall XR |
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20020522 |
N/A |
NDA |
NDA021303 |
Takeda Pharmaceuticals America, 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 (54092-385-01) |
0781-2335-01 |
0781-2335 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270430 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Sandoz 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 (0781-2335-01) |
0781-2371-01 |
0781-2371 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270331 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Sandoz 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 (0781-2371-01) |
66993-597-02 |
66993-597 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270531 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Prasco Laboratories |
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 (66993-597-02) |
54092-383-01 |
54092-383 |
HUMAN PRESCRIPTION DRUG |
Adderall XR |
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20020522 |
N/A |
NDA |
NDA021303 |
Takeda Pharmaceuticals America, 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 (54092-383-01) |
54092-391-01 |
54092-391 |
HUMAN PRESCRIPTION DRUG |
Adderall XR |
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20020522 |
N/A |
NDA |
NDA021303 |
Takeda Pharmaceuticals America, 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 (54092-391-01) |
0781-2352-01 |
0781-2352 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270430 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Sandoz 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 (0781-2352-01) |
66993-595-02 |
66993-595 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270331 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Prasco Laboratories |
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 (66993-595-02) |
66993-599-02 |
66993-599 |
HUMAN PRESCRIPTION DRUG |
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20090402 |
20270331 |
NDA AUTHORIZED GENERIC |
NDA021303 |
Prasco Laboratories |
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 (66993-599-02) |
54092-387-01 |
54092-387 |
HUMAN PRESCRIPTION DRUG |
Adderall XR |
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20020522 |
N/A |
NDA |
NDA021303 |
Takeda Pharmaceuticals America, 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 (54092-387-01) |