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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CEDIPROF INC · Approved 2022-07-05

Drug application

FDA Application #
ANDA210754
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Generic name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
Active ingredients
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
CEDIPROF INC
Manufacturer
Neolpharma, Inc.
First approval
2022-07-05

Source

Authoritative
Drugs@FDA application overview
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