SERTRALINE HYDROCHLORIDE
These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE ORAL SOLUTION. SERTRALINE HYDROCHLORIDEORAL SOLUTION, for oral useInitial U.S. Approval: 1991
Approved
Approval ID
f5da1754-2aed-4777-ad2e-593ee43e6e86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2023
Manufacturers
FDA
ACI Healthcare USA, Inc.
DUNS: 080430318
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SERTRALINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71093-143
Application NumberANDA076934
Product Classification
M
Marketing Category
C73584
G
Generic Name
SERTRALINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2020
FDA Product Classification
INGREDIENTS (2)
SERTRALINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: UTI8907Y6X
Classification: ACTIM
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT