Application 017783

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLUCOTROLGLIPIZIDETABLET;ORAL5MGYesNo
002GLUCOTROLGLIPIZIDETABLET;ORAL10MGYesYes
003GLUCOTROLGLIPIZIDETABLET;ORAL2.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-4110GlucotrolglipizideRoerigNDACurrent
0049-4110GlucotrolglipizideRoerigNDACurrent
0049-4110GlucotrolglipizideRoerigNDACurrent
0049-4120GlucotrolglipizideRoerigNDACurrent
0049-4120GlucotrolglipizideRoerigNDACurrent
0049-4120GlucotrolglipizideRoerigNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45098SUPPL2016-08-22
45144SUPPL2016-08-18
33347SUPPL2013-10-22
702SUPPL2013-10-16
701SUPPL2011-02-09
33346SUPPL2011-02-07
700SUPPL2009-11-19
11062SUPPL2009-09-17
33345SUPPL2008-11-07
13901SUPPL2008-10-29