FDA.report

PAROXETINE

Product NDC
0904-5679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075356
Marketing category
ANDA
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Current FDA listing
Historical FDA.report record

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
0904-5679-61100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5679-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK2003-09-080000-00-00NoCurrent

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: 1992Major Pharmaceuticals2025-08-07HUMAN PRESCRIPTION DRUG LABEL19