FDA.report

Application 203109

Type
NDA
Sponsor
PFIZER

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001REVATIOSILDENAFIL CITRATEFOR SUSPENSION;ORALEQ 10MG BASE/MLYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0336Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0336Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0336Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0336Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
59762-2058Sildenafilsildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2058SildenafilsildenafilGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2058Sildenafilsildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2058Sildenafilsildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
82672SUPPL 2025-06-27
82668SUPPL 2025-06-26
73750SUPPL 2023-03-14
73683SUPPL 2023-03-06
61948SUPPL2020-03-05
61946SUPPL2020-02-24
57317SUPPL2019-01-22
57244SUPPL2019-01-18
50673SUPPL2017-12-13
19429SUPPL2015-05-12
10165SUPPL2015-04-29
40265SUPPL2014-03-13
32378SUPPL2014-03-13
40267SUPPL2014-03-07
32380SUPPL2014-03-07
32379SUPPL2014-02-04
10164SUPPL2014-02-04
40266SUPPL2014-02-03
19428SUPPL2014-02-03
44876ORIG2013-08-09
22912ORIG2013-08-09
10163ORIG2012-09-05
19427ORIG2012-08-31
52342ORIG2012-02-09
52341ORIG2012-02-09
52340ORIG2012-02-09
52339ORIG2012-02-09
52338ORIG2012-02-09
52337ORIG2012-02-09
51665ORIG1900-01-01
51664ORIG1900-01-01
51663ORIG1900-01-01