FDA.reportPublic FDA data

Application 019834

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLENDILFELODIPINETABLET, EXTENDED RELEASE;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002PLENDILFELODIPINETABLET, EXTENDED RELEASE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004PLENDILFELODIPINETABLET, EXTENDED RELEASE;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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
63304-435FELODIPINEEXTENDED-RELEASE TABLETSfelodipineRanbaxy Pharmaceuticals IncNDACurrent
63304-436FELODIPINEEXTENDED-RELEASE TABLETSfelodipineRanbaxy Pharmaceuticals IncNDACurrent
63304-437FELODIPINEEXTENDED-RELEASE TABLETSfelodipineRanbaxy Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19275SUPPL2012-11-05
33998SUPPL2012-11-02
41049SUPPL2008-08-11
20381SUPPL2008-08-11
20379SUPPL2008-08-11
41051SUPPL2008-08-08
41050SUPPL2008-08-08
20383SUPPL2008-08-08
20385SUPPL2008-08-04
20384SUPPL2008-08-04
20382SUPPL2008-08-04
41053SUPPL2008-04-02
41052SUPPL2008-04-02
41048SUPPL2008-04-02
11747SUPPL2004-06-14
1660SUPPL2004-06-14
19274SUPPL2004-06-10
11749SUPPL2004-06-10
41047SUPPL2003-08-07
20380SUPPL2003-08-07
11748SUPPL2002-05-22
1661SUPPL2002-05-22