Fluoxetine
These highlights do not include all the information needed to use FLUOXETINE HYDROCHLORIDE ORAL SOLUTION USP safely and effectively. See full prescribing information for FLUOXETINE HYDROCHLORIDE ORAL SOLUTION USP. FLUOXETINE HYDROCHLORIDE oral solution USP, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
daf40a04-96b4-4f79-995f-33cc9f25316f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-244
Application NumberANDA077849
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluoxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (6)
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FLUOXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 5 mL
Code: I9W7N6B1KJ
Classification: ACTIM