TADALAFIL
1225/1226/1227 TADALAFIL 5/10/20 MG
Approved
Approval ID
8c687cd7-bda3-f812-e053-2995a90abfdd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2019
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TADALAFIL
PRODUCT DETAILS
NDC Product Code76519-1225
Application NumberANDA090141
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 28, 2019
Generic NameTADALAFIL
INGREDIENTS (1)
TADALAFILActive
Quantity: 20 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
TADALAFIL
PRODUCT DETAILS
NDC Product Code76519-1227
Application NumberANDA090141
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 28, 2019
Generic NameTADALAFIL
INGREDIENTS (1)
TADALAFILActive
Quantity: 10 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB
TADALAFIL
PRODUCT DETAILS
NDC Product Code76519-1226
Application NumberANDA090141
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 28, 2019
Generic NameTADALAFIL
INGREDIENTS (1)
TADALAFILActive
Quantity: 5 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB