TADLIQ
These highlights do not include all the information needed to use TADLIQ safely and effectively. See full prescribing information for TADLIQ.TADLIQ (tadalafil) oral suspensionInitial U.S. Approval: 2003
Approved
Approval ID
7a909b25-3772-403e-a5fe-e4a040293fb7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2022
Manufacturers
FDA
CMP Pharma, Inc.
DUNS: 005224175
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 Code46287-045
Application NumberNDA214522
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2022
FDA Product Classification
INGREDIENTS (11)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TadalafilActive
Quantity: 20 mg in 5 mL
Code: 742SXX0ICT
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT