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

Product NDC

57664-338

11-digit product format

576640338

Labeler code

57664

Product ID

57664-338_dc7bba4e-0db3-8ebb-e053-2a95a90aed98

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

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

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Sun Pharmaceutical Industries, Inc.

Application

ANDA211715

Marketing category

ANDA

Marketing start

2020-03-05

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