FDA.reportPublic FDA data

Application 050733

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZITHROMAXAZITHROMYCININJECTABLE;INJECTIONEQ 500MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0400Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3150Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
10019-648azithromycinazithromycinBaxter Healthcare CorporationNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71517SUPPL2022-07-05
71514SUPPL2022-07-05
69405SUPPL2021-11-24
69391SUPPL2021-11-23
58428ORIG2019-04-26
58417SUPPL2019-04-25
47839SUPPL2017-04-03
47788SUPPL2017-03-30
47187SUPPL2017-02-13
47171SUPPL2017-02-13
30410SUPPL2016-05-26
39216SUPPL2016-05-25
39214SUPPL2014-06-10
30407SUPPL2014-06-10
23726ORIG2013-03-12
18143SUPPL2013-02-21
8144SUPPL2013-02-21
18142SUPPL2012-06-11
30409SUPPL2012-06-08
39215SUPPL2011-11-21
30408SUPPL2011-11-21
18141SUPPL2011-02-04
8143SUPPL2011-02-03
39213SUPPL2010-08-19
30406SUPPL2010-08-17
39212SUPPL2009-04-03
30405SUPPL2009-03-03
30404SUPPL2007-11-08
18140SUPPL2007-11-07
30403SUPPL2004-01-22
8142SUPPL2004-01-22
30402SUPPL2003-06-22
39211SUPPL2003-05-02
30401SUPPL2002-10-16
8141SUPPL2002-07-22
8140SUPPL2002-03-13
42708ORIG1997-01-30