Adderall - Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
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Field |
Value |
NDC Code: |
54092-383 |
Proprietary Name: |
Adderall |
Suffix: |
XR |
Non-Proprietary Name: |
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate |
Dosage Form: |
CAPSULE, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
11-10-2001 |
Category Name: |
NDA |
Application Number: |
NDA021303 |
Labeler: |
SHIRE US MANUFACTURING INC. |
Substance Name: |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
Active Numerator Strength: |
2.5; 2.5; 2.5; 2.5 |
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 |