Sertraline Hydrochloride
Sertraline HCL 100mg Tablets
Approved
Approval ID
f8c45a99-18ed-0e1f-e053-6394a90a2d52
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2023
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
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 Code80425-0310
Application NumberANDA077206
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sertraline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (1)
SERTRALINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: UTI8907Y6X
Classification: ACTIM