Quetiapine Fumarate

Product NDC

50090-3595

11-digit product format

500903595

Labeler code

50090

Product ID

50090-3595_0ea95554-1e8f-497f-bc2b-d439d6444367

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Quetiapine

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

A-S Medication Solutions

Application

ANDA207655

Marketing category

ANDA

Marketing start

2017-11-29

Marketing end

0000-00-00

Substance

QUETIAPINE FUMARATE

Active strength

300 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record