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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RHODES PHARMS · Approved 2021-01-13

Drug application

FDA Application #
ANDA213111
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
RHODES PHARMS
Manufacturer
Rhodes Pharmaceuticals LLC
First approval
2021-01-13

Source

Authoritative
Drugs@FDA application overview
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