Citalopram
Citalopram Tablets, USP
Approved
Approval ID
793c9089-8139-4d21-9e8c-64eb0d554063
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0683
Application NumberANDA077031
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2011
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT