DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE

Product NDC

43602-374

11-digit product format

436020374

Labeler code

43602

Product ID

43602-374_82f79db6-1962-4374-8510-0bbf73709a58

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

Dosage form

TABLET

Route

ORAL

Labeler

Ascent Pharmaceuticals, Inc

Application

ANDA213709

Marketing category

ANDA

Marketing start

2021-04-22

Marketing end

0000-00-00

Substance

AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE

Active strength

15 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2022-12-31

Current FDA listing

Historical FDA.report record