43975-282-10 |
43975-282 |
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 |
20200316 |
N/A |
ANDA |
ANDA205401 |
ANI 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 (43975-282-10) |
72162-1377-1 |
72162-1377 |
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 |
20240201 |
N/A |
ANDA |
ANDA205401 |
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 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1377-1) |
72162-1381-1 |
72162-1381 |
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 |
20240201 |
N/A |
ANDA |
ANDA205401 |
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 (72162-1381-1) |
43975-280-10 |
43975-280 |
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 |
20200316 |
N/A |
ANDA |
ANDA205401 |
ANI 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 (43975-280-10) |
43975-281-10 |
43975-281 |
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 |
20200316 |
N/A |
ANDA |
ANDA205401 |
ANI 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 (43975-281-10) |
72162-1380-1 |
72162-1380 |
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 |
20240201 |
N/A |
ANDA |
ANDA205401 |
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 (72162-1380-1) |
43975-279-10 |
43975-279 |
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 |
20200316 |
N/A |
ANDA |
ANDA205401 |
ANI 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 (43975-279-10) |
63629-1975-1 |
63629-1975 |
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 |
20211221 |
N/A |
ANDA |
ANDA205401 |
Bryant Ranch Prepack |
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 (63629-1975-1) |
72162-1379-1 |
72162-1379 |
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 |
20240201 |
N/A |
ANDA |
ANDA205401 |
Bryant Ranch Prepack |
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 (72162-1379-1) |
43975-278-10 |
43975-278 |
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 |
20200316 |
N/A |
ANDA |
ANDA205401 |
ANI 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 (43975-278-10) |
63629-1974-1 |
63629-1974 |
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 |
20211221 |
N/A |
ANDA |
ANDA205401 |
Bryant Ranch Prepack |
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 (63629-1974-1) |
63629-1978-1 |
63629-1978 |
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 |
20211221 |
N/A |
ANDA |
ANDA205401 |
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 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1978-1) |
72162-1378-1 |
72162-1378 |
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 |
20240201 |
N/A |
ANDA |
ANDA205401 |
Bryant Ranch Prepack |
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 (72162-1378-1) |
43975-277-10 |
43975-277 |
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 |
20200316 |
N/A |
ANDA |
ANDA205401 |
ANI 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 (43975-277-10) |
63629-1973-1 |
63629-1973 |
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 |
20211221 |
N/A |
ANDA |
ANDA205401 |
Bryant Ranch Prepack |
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 (63629-1973-1) |
63629-1977-1 |
63629-1977 |
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 |
20211221 |
N/A |
ANDA |
ANDA205401 |
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 (63629-1977-1) |
63629-1976-1 |
63629-1976 |
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 |
20211221 |
N/A |
ANDA |
ANDA205401 |
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 (63629-1976-1) |