DEXEDRINE - dextroamphetamine sulfate
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Field |
Value |
NDC Code: |
52054-512 |
Proprietary Name: |
DEXEDRINE |
Suffix: |
SPANSULE |
Non-Proprietary Name: |
dextroamphetamine sulfate |
Dosage Form: |
CAPSULE, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
02-08-1976 |
Category Name: |
NDA |
Application Number: |
NDA017078 |
Labeler: |
AMEDRA PHARMACEUTICALS LLC |
Substance Name: |
DEXTROAMPHETAMINE SULFATE |
Active Numerator Strength: |
5 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
DEA Schedule: |
CII |