FDA.reportPublic FDA data

Application 011459

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002VISTARILHYDROXYZINE PAMOATECAPSULE;ORALEQ 25MG HYDROCHLORIDEYesNo
004VISTARILHYDROXYZINE PAMOATECAPSULE;ORALEQ 50MG HYDROCHLORIDEYesNo
006VISTARILHYDROXYZINE PAMOATECAPSULE;ORALEQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-5410Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
0069-5410Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
0069-5410Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
0069-5410Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
0069-5420Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
0069-5420Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
0069-5420Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
0069-5420Vistarilhydroxyzine pamoatePfizer Laboratories Div Pfizer IncNDACurrent
59762-5420Hydroxyzine pamoatehydroxyzine pamoateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5420Hydroxyzine pamoatehydroxyzine pamoateGreenstone LLCNDA AUTHORIZED GENERICCurrent
70518-0500Vistarilhydroxyzine pamoateREMEDYREPACK INC.NDACurrent
70518-0500Vistarilhydroxyzine pamoateREMEDYREPACK INC.NDACurrent
70518-0500Vistarilhydroxyzine pamoateREMEDYREPACK INC.NDACurrent
70518-0500Vistarilhydroxyzine pamoateREMEDYREPACK INC.NDACurrent
70518-0500Vistarilhydroxyzine pamoateREMEDYREPACK INC.NDACurrent
70518-3323Hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45869SUPPL2016-11-10
45864SUPPL2016-11-10
33041SUPPL2016-03-10
260SUPPL2016-02-22
11935SUPPL2014-06-05
33040SUPPL2014-06-04
11934SUPPL2004-12-29
11933SUPPL2001-03-21