FDA.reportPublic FDA data

Application 018482

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCARDIANIFEDIPINECAPSULE;ORAL10MGYesYes
002PROCARDIANIFEDIPINECAPSULE;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-2600ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2600ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
59762-1004nifedipinenifedipineGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33499SUPPL2015-01-29
933SUPPL2015-01-12
11228SUPPL2013-07-30
15018SUPPL2013-07-29
33498SUPPL2011-09-30
15017SUPPL2011-09-29
15016SUPPL2002-02-22