Application 050711

Type
NDA
Sponsor
PFIZER

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050711-001ZITHROMAXAZITHROMYCINEQ 250MG BASETABLET / ORALABRLD1996-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050711-001AB

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050711-001ZITHROMAXEQ 250MG BASETABLET / ORALABRLD1996-07-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050711-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050711-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050711-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050711-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050711-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050711-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050711-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050711-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050711-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050711-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050711-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050711-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050711-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050711-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050711-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050711-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050711-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050711-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050711-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050711-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050711-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050711-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050711-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050711-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050711-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050711-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050711-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050711-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050711-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050711-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050711-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050711-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050711-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050711-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050711-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050711-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050711-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050711-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050711-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050711-001AB1cb3db0bc1861…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 050711
application number: NDA050711
ndc (product): 0069-3060
ndc (product): 0069-4061
ZithromaxAZITHROMYCIN DIHYDRATERedpharm Drug3ddecd25-dc32-a2af-e063-6294a90a526d2025-09-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 050711
application number: NDA050711

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

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