Mavik
MAVIK®(trandolapril tablets)
Approved
Approval ID
bcaffc12-69af-46a8-a092-b3f66a0508d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trandolapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5099
Application NumberNDA020528
Product Classification
M
Marketing Category
C73594
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRANDOLAPRILActive
Quantity: 4 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT