Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC

0527-1501

11-digit product format

005271501

Labeler code

0527

Product ID

0527-1501_c8e3e12d-63f1-451f-ab4e-51c7ec63cecf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Dosage form

TABLET

Route

ORAL

Labeler

Lannett Company, Inc.

Application

ANDA211352

Marketing category

ANDA

Marketing start

2018-12-12

Marketing end

0000-00-00

Substance

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

Active strength

2 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2023-12-31

Current FDA listing

Historical FDA.report record