Stendra
These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA (avanafil) tablets, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
fa7d93e3-b69b-4e02-8146-89760cd8e9d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2023
Manufacturers
FDA
Metuchen Pharmaceuticals, LLC
DUNS: 080405758
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
avanafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72384-752
Application NumberNDA202276
Product Classification
M
Marketing Category
C73594
G
Generic Name
avanafil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2020
FDA Product Classification
INGREDIENTS (8)
AVANAFILActive
Quantity: 100 mg in 1 1
Code: DR5S136IVO
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW)Inactive
Code: 7773C1ROEU
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
avanafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72384-753
Application NumberNDA202276
Product Classification
M
Marketing Category
C73594
G
Generic Name
avanafil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2020
FDA Product Classification
INGREDIENTS (8)
AVANAFILActive
Quantity: 200 mg in 1 1
Code: DR5S136IVO
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW)Inactive
Code: 7773C1ROEU
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
avanafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72384-751
Application NumberNDA202276
Product Classification
M
Marketing Category
C73594
G
Generic Name
avanafil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2020
FDA Product Classification
INGREDIENTS (8)
AVANAFILActive
Quantity: 50 mg in 1 1
Code: DR5S136IVO
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW)Inactive
Code: 7773C1ROEU
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT