Dextroamphetamine Sulfate

Product NDC
0378-1070
11-digit product format
003781070
Labeler code
0378
Product ID
0378-1070_ab5250ef-0765-4895-b3bd-ebe867ce6382
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206735
Marketing category
ANDA
Marketing start
2016-07-20
Marketing end
2019-07-31
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record