FDA.reportPublic FDA data

Application 020329

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLUCOTROL XLGLIPIZIDETABLET, EXTENDED RELEASE;ORAL5MGYesNo
002GLUCOTROL XLGLIPIZIDETABLET, EXTENDED RELEASE;ORAL10MGYesYes
003GLUCOTROL XLGLIPIZIDETABLET, EXTENDED RELEASE;ORAL2.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-0170GlucotrolglipizideRoerigNDACurrent
0049-0170GlucotrolglipizideRoerigNDACurrent
0049-0170GlucotrolglipizideRoerigNDACurrent
0049-0174GlucotrolglipizideRoerigNDACurrent
0049-0174GlucotrolglipizideRoerigNDACurrent
0049-0174GlucotrolglipizideRoerigNDACurrent
0049-0178GlucotrolglipizideRoerigNDACurrent
0049-0178GlucotrolglipizideRoerigNDACurrent
0049-0178GlucotrolglipizideRoerigNDACurrent
51655-361GlipizideglipizideNorthwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
51655-361GlipizideglipizideNorthwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
53808-0408Glipizide XLglipizideState of Florida DOH Central PharmacyNDACurrent
53808-0409Glipizide XLglipizideState of Florida DOH Central PharmacyNDACurrent
53808-0942GlipizideglipizideState of Florida DOH Central PharmacyNDA AUTHORIZED GENERICCurrent
55154-0539GlipizideglipizideCardinal HealthNDACurrent
59762-0540GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0540GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0540GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0541GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0541GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0541GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0542GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0542GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0542GlipizideglipizideGreenstone LLCNDA AUTHORIZED GENERICCurrent
70934-391GlipizideglipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
70934-391GlipizideglipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
70934-391GlipizideglipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68587SUPPL2021-09-13
68584SUPPL2021-09-13
55200SUPPL2018-08-17
55170SUPPL2018-08-13
49569SUPPL2017-08-29
49446SUPPL2017-08-17
12452SUPPL2015-10-08
2337SUPPL2015-10-06
12451SUPPL2013-10-22
24786SUPPL2013-10-16
2336SUPPL2011-02-09
12450SUPPL2011-02-07
34507SUPPL2009-09-17
12449SUPPL2008-11-07
2335SUPPL2008-10-29
41281SUPPL2007-07-09
41280SUPPL2006-10-25
24785SUPPL2003-09-29
24784SUPPL2002-04-01
12448SUPPL2002-04-01