Home Applications 050784 Application 050784
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZITHROMAX AZITHROMYCIN TABLET;ORAL EQ 500MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050784-001 ZITHROMAX AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050784-001 AB
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050784-001 ZITHROMAX EQ 500MG BASE TABLET / ORAL AB RLD 2002-05-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zithromax AZITHROMYCIN DIHYDRATE Pfizer Laboratories Div Pfizer Inc db52b91e-79f7-4cc1-9564-f2eee8e31c45 2026-07-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 050784 application number: NDA050784 ndc (product): 0069-3070
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 29 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3070 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 35356-798 azithromycin azithromycin Lake Erie Medical DBA Quality Care Products LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3070 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 63629-6764 azithromycin azithromycin Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-6764 azithromycin azithromycin Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 70518-0336 Zithromax azithromycin dihydrate REMEDYREPACK INC. NDA Current 70518-0336 Zithromax azithromycin dihydrate REMEDYREPACK INC. NDA Current 70518-0336 Zithromax azithromycin dihydrate REMEDYREPACK INC. NDA Current 70518-0336 Zithromax azithromycin dihydrate REMEDYREPACK INC. NDA Current 70518-0336 Zithromax azithromycin dihydrate REMEDYREPACK INC. NDA Current 70518-0336 Zithromax azithromycin dihydrate REMEDYREPACK INC. NDA Current 70518-0336 Zithromax azithromycin dihydrate REMEDYREPACK INC. NDA Current