FDA.reportPublic FDA data

Application 050730

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZITHROMAXAZITHROMYCINTABLET;ORALEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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
0069-3080ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3080ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3080ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3080ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div PNDACurrent
59762-3080azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3080azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3080azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3080azithromycinAZITHROMYCINGreenstone LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69393SUPPL2021-11-23
69374SUPPL2021-11-22
58433SUPPL2019-04-26
58414SUPPL2019-04-25
47837SUPPL2017-04-03
47784SUPPL2017-03-30
47184SUPPL2017-02-13
47183SUPPL2017-02-10
30400SUPPL2016-05-25
18139SUPPL2016-05-25
8137SUPPL2014-06-11
39208SUPPL2014-06-10
23725ORIG2013-03-12
39210SUPPL2013-02-21
8139SUPPL2013-02-21
39207SUPPL2012-11-06
30399SUPPL2012-11-06
39209SUPPL2012-06-11
8138SUPPL2012-06-08
18138SUPPL2011-02-04
30398SUPPL2011-02-03
39206SUPPL2010-08-19
8136SUPPL2010-08-17
39205SUPPL2009-04-23
8135SUPPL2009-03-10
8134SUPPL2007-11-08
39204SUPPL2007-11-07
39203SUPPL2004-04-05
30396SUPPL2004-03-28
30397SUPPL2004-01-22
30395SUPPL2002-10-16
8133SUPPL2002-07-22
39202SUPPL2000-11-13
30394SUPPL2000-11-13
22210SUPPL2000-11-13