Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release

Product NDC

71335-1415

11-digit product format

713351415

Labeler code

71335

Product ID

71335-1415_6f5c10c5-e0b7-4ce4-8d29-3221ed711385

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

ANDA210651

Marketing category

ANDA

Marketing start

2019-08-22

Marketing end

0000-00-00

Substance

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

Active strength

3 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

2021-12-31

Current FDA listing

Historical FDA.report record