Citalopram Hydrobromide
Citalopram Oral Solution, USP Rx Only
Approved
Approval ID
e7a2cbdd-1bdb-4e59-a3dd-298a189753ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Citalopram Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-074
Application NumberANDA077812
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (6)
CITALOPRAM HYDROBROMIDEActive
Quantity: 10 mg in 5 mL
Code: I1E9D14F36
Classification: ACTIM
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT