Quetiapine Fumarate

Product NDC
68071-3599
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA201504
Marketing category
ANDA
Substance
QUETIAPINE FUMARATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
68071-3599-660 TABLET in 1 BOTTLE (68071-3599-6) 20240426NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
16f48034-b8c9-ab2b-e063-6294a90adf65These 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.2024-04-25HUMAN PRESCRIPTION DRUG LABEL1