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citalopram

These highlights do not include all the information needed to use CITALOPRAM CAPSULES safely and effectively. See full prescribing information for CITALOPRAM CAPSULES. CITALOPRAM capsules, for oral use Initial U.S. Approval: 1998

Approved
Approval ID

2f815b0c-6da7-cb61-e89c-7de628092d0d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 24, 2023

Manufacturers
FDA

Almatica Pharma LLC

DUNS: 962454505

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

citalopram

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52427-691
Application NumberNDA215428
Product Classification
M
Marketing Category
C73594
G
Generic Name
citalopram
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2022
FDA Product Classification

INGREDIENTS (10)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 30 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 2/9/2022

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/9/2022

1 INDICATIONS AND USAGE

Citalopram Capsules are indicated for the treatment of Major Depressive Disorder (MDD) in adults [see Clinical Studies (14)].

Key Highlight

Citalopram Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for treatment of Major Depressive Disorder (MDD) in adults. (1)

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 8/18/2023

RECENT MAJOR CHANGES

Warnings and Precautions (5.3, 5.4)

8/2023

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citalopram - FDA Drug Approval Details