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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NUVO PHARM · Approved 2017-12-28

Drug application

FDA Application #

ANDA209799

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 AND AMPHETAMINE SULFATE

Active ingredients

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NUVO PHARM

Manufacturer

SUNRISE PHARMACEUTICAL, INC.

First approval

2017-12-28

Source

Authoritative

Drugs@FDA application overview

Machine

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