Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release

Product NDC

63629-9478

11-digit product format

636299478

Labeler code

63629

Product ID

63629-9478_9a75f4a2-26a2-408b-b557-0ce01ce93a1c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

ANDA210651

Marketing category

ANDA

Marketing start

2019-08-22

Marketing end

0000-00-00

Substance

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

Active strength

4 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