NDC Code: |
0228-3062 |
Proprietary Name: |
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate |
Suffix: |
|
Non-Proprietary Name: |
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate |
Dosage Form: |
CAPSULE, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
10-12-2012 |
Category Name: |
ANDA |
Application Number: |
ANDA077302 |
Labeler: |
ACTAVIS ELIZABETH LLC |
Substance Name: |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
Active Numerator Strength: |
1.25; 1.25; 1.25; 1.25 |
Active Ingredient Unit: |
mg/1; mg/1; mg/1; mg/1 |
Pharm Classes: |
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
DEA Schedule: |
CII |