Quetiapine fumarate

Product NDC

55700-085

11-digit product format

557000085

Labeler code

55700

Product ID

55700-085_70cf510c-a514-4ec6-b795-5ac358c00570

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Quetiapine fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA201190

Marketing category

ANDA

Marketing start

2012-03-28

Marketing end

0000-00-00

Substance

QUETIAPINE FUMARATE

Active strength

100 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record