Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ER

Product NDC

49884-839

11-digit product format

498840839

Labeler code

49884

Product ID

49884-839_1412a044-59ea-421e-b4b6-2d435d0d8d55

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ER

Dosage form

CAPSULE

Route

ORAL

Labeler

Par Pharmaceutical, Inc.

Application

ANDA206159

Marketing category

ANDA

Marketing start

2019-06-25

Marketing end

0000-00-00

Substance

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Active strength

1 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 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