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001ZITHROMAXAZITHROMYCINTABLET;ORALEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050730-001ZITHROMAXAZITHROMYCINEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N050730-001ZITHROMAXEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050730-001ZITHROMAXEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050730-001ZITHROMAXEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N050730-001AB1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.94e17ae5-0871-67a0-e053-2995a90ae0ae2026-09-09Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINREMEDYREPACK INC.da399401-1ee6-422a-be46-0bba6b264b2f2026-09-08Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAurobindo Pharma Limited3c902990-b870-4725-b9fe-76b8be633e1c2026-09-03Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12026-09-02Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINREMEDYREPACK INC.bf061799-cdef-40f8-b1ce-bc5eb609f8c32026-09-02Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAurobindo Pharma Limited795c13cd-e9ca-481b-9fa9-2890bdf9dac82026-09-02Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.01649d79-4677-4577-a3e4-e054f3f9fc3b2026-08-20Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.c9990a1d-5238-403e-9221-72a9314d7b5e2026-08-20Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINZydus Pharmaceuticals USA Inc.99e5bd22-a721-4e2e-a46c-d61a53c25c3d2026-08-14Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINREMEDYREPACK INC.614cc2a4-3fc7-455d-9e8a-212c496f0fbf2026-08-05Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSandoz Inc34b70c23-92a6-460f-8dbb-15a0e6b9d3a92026-07-30Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.a9cdb5ae-2aeb-c598-e053-2a95a90a80622026-07-30Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2026-07-30Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions882f71b1-b153-4856-b4a7-1a29ae9cf2472026-07-29Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINEugia US LLC7b81436e-d14a-4353-a22d-253f45e2e5762026-07-27Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsName fallback
brand name: Zithromax
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Inc3b631aa1-2d46-40bc-a614-d698301ea4f92026-07-24Warnings, Adverse reactionsName fallback
brand name: Zithromax
AzithromycinAZITHROMYCINA-S Medication Solutions3b7e16b1-9a3c-4e3a-8411-841a708afe452026-07-23Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions58308e8b-57bd-4e82-a2e8-24aac63194cd2026-07-23Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINBryant Ranch Prepack2a8010dc-700f-45d3-94ca-ebe4a51acc1b2026-07-20Warnings, Adverse reactionsName fallback
generic name: AZITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

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