Ambrisentan
These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for . AMBRISENTAN tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
32549c43-f8ff-422c-b42d-ca0877e661cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2019
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ambrisentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-2406
Application NumberANDA208252
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ambrisentan
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2019
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMBRISENTANActive
Quantity: 10 mg in 1 1
Code: HW6NV07QEC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Ambrisentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-2405
Application NumberANDA208252
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ambrisentan
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2019
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
AMBRISENTANActive
Quantity: 5 mg in 1 1
Code: HW6NV07QEC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 9/30/2019