FDA.report

Quetiapine fumarate

Product NDC
47335-906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA201190
Marketing category
ANDA
Substance
QUETIAPINE FUMARATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
47335-906-181000 TABLET, FILM COATED in 1 BOTTLE (47335-906-18) 2012-03-28NoHistorical
47335-906-6110 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-906-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK2012-03-28NoHistorical
47335-906-8330 TABLET, FILM COATED in 1 BOTTLE (47335-906-83) 2012-03-28NoHistorical
47335-906-8660 TABLET, FILM COATED in 1 BOTTLE (47335-906-86) 2012-03-28NoHistorical
47335-906-88100 TABLET, FILM COATED in 1 BOTTLE (47335-906-88) 2012-03-28NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997Bryant Ranch Prepack2025-04-24HUMAN PRESCRIPTION DRUG LABEL7
These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2025-03-03Human Prescription Drug Label23
These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997NuCare Pharmaceuticals,Inc.2022-05-23HUMAN PRESCRIPTION DRUG LABEL1