Home Applications 050710 Application 050710
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZITHROMAX AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Yes No 002 ZITHROMAX AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050710-001 ZITHROMAX AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 N050710-002 ZITHROMAX AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050710-001 ZITHROMAX EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1995-10-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050710-002 ZITHROMAX EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1995-10-19 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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): 050710 application number: NDA050710
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 105 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3130 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-3140 azithromycin azithromycin Greenstone LLC NDA AUTHORIZED GENERIC Current 68071-2529 azithromycin azithromycin NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 76413-148 azithromycin azithromycin Central Texas Community Health Centers NDA AUTHORIZED GENERIC Current 76413-149 azithromycin azithromycin Central Texas Community Health Centers NDA AUTHORIZED GENERIC Current 76413-157 azithromycin azithromycin Central Texas Community Health Centers NDA AUTHORIZED GENERIC Current