FDA.reportPublic FDA data

Application 022473

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REVATIOSILDENAFIL CITRATESOLUTION;INTRAVENOUSEQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0338Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0338Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0338Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0338Revatiosildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85167SUPPL 2026-02-19
85166SUPPL 2026-02-19
73688SUPPL 2023-03-06
73684SUPPL 2023-03-06
57316SUPPL2019-01-22
57243SUPPL2019-01-18
50674SUPPL2017-12-13
17631SUPPL2015-05-12
29767SUPPL2015-04-29
38750SUPPL2014-03-13
7443SUPPL2014-03-13
38752SUPPL2014-03-07
7446SUPPL2014-03-07
7445SUPPL2014-02-04
7444SUPPL2014-02-04
38751SUPPL2014-02-03
17630SUPPL2014-02-03
17629SUPPL2012-09-06
7442SUPPL2012-09-05
17628SUPPL2010-11-26
29766SUPPL2010-11-22
42534ORIG2010-02-18
24317ORIG2010-02-18
38749ORIG2009-11-20
7441ORIG2009-11-20