MedPath

Citalopram Hydrobromide

Citalopram Tablets USP

Approved
Approval ID

a78d434f-66dc-4923-90f8-7159cbc83c4e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2011

Manufacturers
FDA

TYA Pharmaceuticals

DUNS: 938389038

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 Code64725-0010
Application NumberANDA078216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2011
FDA Product Classification

INGREDIENTS (1)

CITALOPRAM HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Citalopram Hydrobromide - FDA Drug Approval Details