Home Applications 050733 Application 050733
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZITHROMAX AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050733-001 ZITHROMAX AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1997-01-30
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 · 43 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 2026-09-14 22:38:34 2026-08 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1997-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION RLD 1997-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050733-001 ZITHROMAX EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-01-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 3b631aa1-2d46-40bc-a614-d698301ea4f9 2026-07-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 050733 application number: NDA050733 ndc (product): 0069-3150
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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0400 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-3150 Zithromax azithromycin dihydrate Pfizer Laboratories Div Pfizer Inc NDA Current 10019-648 azithromycin azithromycin Baxter Healthcare Corporation NDA AUTHORIZED GENERIC Current