FDA.report

PAROXETINE

Product NDC
50090-5566
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075356
Marketing category
ANDA
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Current FDA listing
Historical FDA.report record

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
50090-5566-032 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5566-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK2021-06-220000-00-00NoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE TABLETS, for oral use Initial U.S. Approval: 1992A-S Medication Solutions2021-07-26HUMAN PRESCRIPTION DRUG LABEL1