CIALIS
These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablet, film coated for oral use Initial U.S. Approval: 2003
Approved
Approval ID
6a8621eb-7415-42a6-9432-630751d34c6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TADALAFIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-905
Application NumberNDA021368
Product Classification
M
Marketing Category
C73594
G
Generic Name
TADALAFIL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2010
FDA Product Classification
INGREDIENTS (12)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TADALAFILActive
Quantity: 10 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT