FDA.reportPublic FDA data

Application 050693

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZITHROMAXAZITHROMYCINFOR SUSPENSION;ORALEQ 1GM BASE/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div PNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer IncNDACurrent
53002-2225azithromycinAZITHROMYCINRPK Pharmaceuticals, Inc.NDACurrent
53002-2225azithromycinAZITHROMYCINRPK Pharmaceuticals, Inc.NDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
59762-3051azithromycinAZITHROMYCINGreenstone LLCNDACurrent
68258-3051azithromycinazithromycinDispensing Solutions, Inc.NDACurrent
68788-0713azithromycinAZITHROMYCINPreferred Pharmaceuticals, Inc.NDACurrent
68788-0713azithromycinAZITHROMYCINPreferred Pharmaceuticals, Inc.NDACurrent
68788-0713azithromycinAZITHROMYCINPreferred Pharmaceuticals, Inc.NDACurrent
68788-0713azithromycinAZITHROMYCINPreferred Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69392SUPPL2021-11-23
69375SUPPL2021-11-22
58432SUPPL2019-04-26
58415SUPPL2019-04-25
47838SUPPL2017-04-03
47785SUPPL2017-03-30
47181SUPPL2017-02-13
47182SUPPL2017-02-10
39128SUPPL2016-05-25
30293SUPPL2016-05-25
30291SUPPL2014-06-11
39127SUPPL2014-06-10
44203ORIG2013-03-12
30292SUPPL2013-02-21
18033SUPPL2013-02-21
39126SUPPL2012-11-06
8020SUPPL2012-11-06
18032SUPPL2012-06-11
8021SUPPL2012-06-08
18031SUPPL2011-02-04
30290SUPPL2011-02-03
39125SUPPL2010-08-19
8019SUPPL2010-08-17
18030SUPPL2009-04-03
30289SUPPL2009-03-10
30288SUPPL2007-11-08
39124SUPPL2007-11-07
18029SUPPL2004-04-05
30287SUPPL2004-03-28
8018SUPPL2004-01-22
8016SUPPL2002-10-16
8017SUPPL2002-07-22
42681SUPPL2000-11-13
39123SUPPL2000-11-13
8015SUPPL2000-11-13