Application 022026

Type
NDA
Sponsor
SYNTHON PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET, ORALLY DISINTEGRATING;ORALEQ 2.5MG BASENoNo
002AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET, ORALLY DISINTEGRATING;ORALEQ 5MG BASENoNo
003AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET, ORALLY DISINTEGRATING;ORALEQ 10MG BASENoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42391ORIG2009-02-02
24233ORIG2009-02-02
16793ORIG2007-10-04
6715ORIG2007-10-04