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

Product NDC

43975-336

11-digit product format

439750336

Labeler code

43975

Product ID

43975-336_dd10c2a1-9bf7-4603-84a1-c122952c39a0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Amerigen Pharmaceuticals Inc.

Application

NDA021303

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2018-12-03

Marketing end

2023-01-31

Substance

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

Active strength

8 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