FDA.reportPublic FDA data

Application 021845

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REVATIOSILDENAFIL CITRATETABLET;ORALEQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-4190Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4190Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4190Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4190Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0179-0160Sildenafilsildenafil citrateKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
43063-550Sildenafilsildenafil citratePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-550Sildenafilsildenafil citratePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-550Sildenafilsildenafil citratePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43353-345Sildenafilsildenafil citrateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
50436-0033Sildenafilsildenafil citrateUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
50436-0033Sildenafilsildenafil citrateUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
50436-0034SildenafilsildenafilUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
59762-0033Sildenafilsildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0033Sildenafilsildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0033SildenafilsildenafilGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0033Sildenafilsildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0033Sildenafilsildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85169SUPPL 2026-02-19
85168SUPPL 2026-02-19
73718SUPPL 2023-03-10
73364SUPPL 2023-02-02
73351SUPPL 2023-02-01
52301SUPPL2018-02-02
52259SUPPL2018-02-02
49267SUPPL2017-08-08
37753SUPPL2015-05-12
6295SUPPL2015-04-29
44155ORIG2014-06-20
37750SUPPL2014-03-13
28701SUPPL2014-03-13
37752SUPPL2014-03-07
28703SUPPL2014-03-07
28702SUPPL2014-02-04
6294SUPPL2014-02-04
37751SUPPL2014-02-03
16450SUPPL2014-02-03
6293SUPPL2012-09-05
37749SUPPL2012-08-31
16449SUPPL2010-11-26
6292SUPPL2010-11-22
6291SUPPL2009-05-13
16448SUPPL2009-05-11
37748SUPPL2009-02-20
28700SUPPL2009-02-19
6290SUPPL2008-01-09
16447SUPPL2007-12-27
28699SUPPL2006-08-04
24140SUPPL2006-08-04
6289SUPPL2006-07-21
21839ORIG2005-12-02
28698SUPPL2005-11-18
37747ORIG2005-06-07
6288ORIG2005-06-07