FDA.reportPublic FDA data

Application 019684

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCARDIA XLNIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGYesNo
002PROCARDIA XLNIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGYesNo
003PROCARDIA XLNIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-2650ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2650ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2650ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2660ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2660ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2660ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2670ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2670ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
0069-2670ProcardianifedipinePfizer Laboratories Div Pfizer IncNDACurrent
53808-0496nifedipineNIFEDIPINEState of Florida DOH Central PharmacyNDACurrent
59762-6690nifedipinenifedipineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6690nifedipinenifedipineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6691nifedipinenifedipineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6691nifedipinenifedipineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6692nifedipinenifedipineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-6692nifedipinenifedipineGreenstone LLCNDA AUTHORIZED GENERICCurrent
67046-515nifedipinenifedipineContract Pharmacy Services-PANDACurrent
70518-0600ProcardianifedipineREMEDYREPACK INC.NDACurrent
70518-0600ProcardianifedipineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69771SUPPL2021-12-27
69287SUPPL2021-11-10
11636SUPPL2015-01-14
19101SUPPL2015-01-12
33871SUPPL2014-05-12
19100SUPPL2014-05-08
33870SUPPL2013-07-30
1511SUPPL2013-07-29
19099SUPPL2011-10-03
33869SUPPL2011-09-30
1510SUPPL2010-10-07
33868SUPPL2010-10-04
20288SUPPL1997-01-08