FDA.reportPublic FDA data

Application 050711

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZITHROMAXAZITHROMYCINTABLET;ORALEQ 250MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-3060Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4061Zithromaxazithromycin dihydratePfizer Laboratories Div Pfizer IncNDACurrent
50090-0603Zithromaxazithromycin dihydrateA-S Medication SolutionsNDACurrent
50090-0603Zithromaxazithromycin dihydrateA-S Medication SolutionsNDACurrent
55154-0525azithromycinazithromycinCardinal HealthNDA AUTHORIZED GENERICCurrent
55154-2713ZithromaxazithromycinCardinal HealthNDACurrent
55695-006azithromycinazithromycinDepartment of State Health Services, Pharmacy BranchNDA AUTHORIZED GENERICCurrent
55700-206azithromycinazithromycinLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2198azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3060azithromycinazithromycinGreenstone LLCNDA AUTHORIZED GENERICCurrent
68071-2543azithromycinazithromycinNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68788-9038azithromycinazithromycinPreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-9038azithromycinazithromycinPreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-0249Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0249Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0249Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0249Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0249Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0505Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0505Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0505Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0505Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-0505Zithromaxazithromycin dihydrateREMEDYREPACK INC.NDACurrent
70518-2708azithromycinazithromycinREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2708azithromycinazithromycinREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2708azithromycinazithromycinREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2708azithromycinazithromycinREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71610-381azithromycinazithromycinAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
76413-101azithromycinazithromycinCentral Texas Community Health CentersNDA AUTHORIZED GENERICCurrent
76413-102azithromycinazithromycinCentral Texas Community Health CentersNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70171SUPPL2022-02-15
69418SUPPL2021-11-24
69372SUPPL2021-11-22
58419SUPPL2019-04-25
58396SUPPL2019-04-24
47834SUPPL2017-04-03
47797SUPPL2017-03-31
47189SUPPL2017-02-13
47173SUPPL2017-02-13
18083SUPPL2016-05-25
8075SUPPL2016-05-25
30336SUPPL2014-06-11
18080SUPPL2014-06-10
23723ORIG2013-03-12
30338SUPPL2013-02-21
18082SUPPL2013-02-21
30335SUPPL2012-11-06
18079SUPPL2012-11-06
18081SUPPL2012-06-11
30337SUPPL2012-06-08
18078SUPPL2011-02-04
8074SUPPL2011-02-03
39162SUPPL2010-08-19
30334SUPPL2010-08-17
18077SUPPL2009-04-03
8073SUPPL2009-03-03
8072SUPPL2007-11-08
39161SUPPL2007-11-07
22194ORIG2005-08-04
42687SUPPL2004-06-04
39160SUPPL2004-01-22
39159SUPPL2004-01-22
30332SUPPL2004-01-22
8071SUPPL2004-01-22
30333SUPPL2003-12-22
30330SUPPL2002-10-16
8070SUPPL2002-07-22
30331SUPPL2002-05-24
18076SUPPL2002-05-24