Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC

0185-0401

11-digit product format

001850401

Labeler code

0185

Product ID

0185-0401_9cc3fec2-8210-42ba-9d0e-3828e8c176fb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Dosage form

TABLET

Route

ORAL

Labeler

Eon Labs, Inc.

Application

ANDA040439

Marketing category

ANDA

Marketing start

2002-06-14

Marketing end

2019-06-30

Substance

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

Active strength

5 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

0000-00-00

Current FDA listing

Historical FDA.report record