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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS USA · Approved 2022-01-31

Drug application

FDA Application #
ANDA210876
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
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
TEVA PHARMS USA
Manufacturer
Teva Pharmaceuticals, Inc.
First approval
2022-01-31

Source

Authoritative
Drugs@FDA application overview
Machine
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