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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ · Approved 2002-06-14

Drug application

FDA Application #
ANDA040439
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Generic name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Active ingredients
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
SANDOZ
Manufacturer
Sandoz Inc
First approval
2002-06-14

Source

Authoritative
Drugs@FDA application overview
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