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DEXTROAMPHETAMINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: WINDER LABS LLC · Approved 2021-06-07

Drug application

FDA Application #
ANDA212160
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
WINDER LABS LLC
Manufacturer
Winder Laboratories LLC
First approval
2021-06-07

Source

Authoritative
Drugs@FDA application overview
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