dextroamphetamine sulfate

Product NDC

76181-002

11-digit product format

761810002

Labeler code

76181

Product ID

76181-002_91bdcfb7-5419-4568-e053-2a95a90a7e59

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

dextroamphetamine sulfate

Dosage form

SOLUTION

Route

ORAL

Labeler

Avadel Generics, LLC

Application

ANDA040776

Marketing category

ANDA

Marketing start

2014-01-06

Marketing end

2020-09-30

Substance

DEXTROAMPHETAMINE SULFATE

Active strength

5 mg/5mL

Pharmacologic classes

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