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Citalopram

CITALOPRAM TABLETS USP474047414742Rx only

Approved
Approval ID

871a7ee6-f420-427b-b0e1-b5516d7e1593

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2011

Manufacturers
FDA

Blenheim Pharmacal, Inc.

DUNS: 171434587

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 Code10544-149
Application NumberANDA077048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2011
FDA Product Classification

INGREDIENTS (10)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

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Citalopram - FDA Drug Approval Details