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DEXTROAMPHETAMINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2016-03-16

Drug application

FDA Application #
ANDA204330
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXTROAMPHETAMINE SULFATE
Generic name
DEXTROAMPHETAMINE SULFATE
Active ingredients
DEXTROAMPHETAMINE SULFATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
NOVEL LABS INC
Manufacturer
Lupin Pharmaceuticals,Inc.
First approval
2016-03-16

Source

Authoritative
Drugs@FDA application overview
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