avanafil Oral Tablet

Brand(s)
Stendra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Vivus, Inc. (2015-09-11)
Oldest Current Product
2013-12-27
License(s)
NDA
RxNORM
ORAL TABLET\AVANAFIL
FDAOB
ORAL\TABLET\AVANAFIL
SPL Active
ORAL\TABLET\AVANAFIL
SPL Moiety
ORAL\TABLET\AVANAFIL

product(s) by strength(s)

avanafil 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625410302StendraNDAVivus, Inc.2013-12-27AVANAFILORALTABLETNDA202276f5172788-e1ab-45f9-99fa-878ee42cf91d

avanafil 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625410303StendraNDAVivus, Inc.2013-12-27AVANAFILORALTABLETNDA202276f5172788-e1ab-45f9-99fa-878ee42cf91d

avanafil 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625410301StendraNDAVivus, Inc.2013-12-27AVANAFILORALTABLETNDA202276f5172788-e1ab-45f9-99fa-878ee42cf91d

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202276STENDRAVIVUS INC2012-04-27p7501409, SUBSTANCE
p6656935, TREATMENT OF ERECTILE DYSFUNCTION, SUBSTANCE
REVISED DOSING SCHEDULE TO ADMINISTER AVANAFIL 15 MINUTES PRIOR TO SEXUAL ACTIVITY [2017-09-17]
NEW CHEMICAL ENTITY [2017-04-27]
NDA202276_001, NDA202276_002, NDA202276_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202276_001RXAVANAFIL (50MG)ORALTABLETFalse2012-04-27STENDRA
2NDA202276_002RXAVANAFIL (100MG)ORALTABLETFalse2012-04-27STENDRA
3NDA202276_003RXAVANAFIL (200MG)ORALTABLETTrue2012-04-27STENDRA

patent(s)

#idexpiration dateapplication(s)
1p6656935 (view patent)2020-09-13NDA202276
2p7501409 (view patent)2023-05-05NDA202276

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1f5172788-e1ab-45f9-99fa-878ee42cf91d (view SPL)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 useInitial U.S. Approval: 2012prescriptionHuman PrescriptionVivus, Inc.2015-09-1114625410301, 625410302, 625410303

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII