Home Applications 208249 Application 208249
Type ANDA
Sponsor CSPC OUYI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AZITHROMYCIN AZITHROMYCIN TABLET;ORAL EQ 500MG BASE No No
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 A208249-001 AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208249-001 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 · 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 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208249-001 AZITHROMYCIN EQ 500MG BASE TABLET / ORAL AB 2018-10-25 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 2 of 2 · 21 matching rows.
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 · 39 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-4528 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50090-4528 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50090-4528 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50090-4606 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50090-4606 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50090-4606 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50090-4700 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50090-4700 Azithromycin Dihydrate Azithromycin Dihydrate A-S Medication Solutions ANDA Current 50268-076 Azithromycin Dihydrate Azithromycin Dihydrate AvPAK ANDA Current 50268-076 Azithromycin Dihydrate Azithromycin Dihydrate AvPAK ANDA Current 50268-076 Azithromycin Dihydrate Azithromycin Dihydrate AvPAK ANDA Current 51224-122 Azithromycin Dihydrate Azithromycin Dihydrate TAGI Pharma, Inc. ANDA Current 51224-122 Azithromycin Dihydrate Azithromycin Dihydrate TAGI Pharma, Inc. ANDA Current 53002-0474 Azithromycin Dihydrate Azithromycin Dihydrate RPK Pharmaceuticals, Inc. ANDA Current 53002-7221 Azithromycin Dihydrate Azithromycin Dihydrate RPK Pharmaceuticals, Inc. ANDA Current 55700-896 Azithromycin Dihydrate Azithromycin Dihydrate Quality Care Products, LLC ANDA Current 68071-2775 Azithromycin Dihydrate Azithromycin Dihydrate NuCare Pharmceuticals,Inc. ANDA Current 68071-2775 Azithromycin Dihydrate Azithromycin Dihydrate NuCare Pharmceuticals,Inc. ANDA Current 68788-8311 Azithromycin Dihydrate Azithromycin Dihydrate Preferred Pharmaceuticals Inc. ANDA Current 70518-3168 Azithromycin Dihydrate Azithromycin Dihydrate REMEDYREPACK INC. ANDA Current 70518-3168 Azithromycin Dihydrate Azithromycin Dihydrate REMEDYREPACK INC. ANDA Current 70518-3168 Azithromycin Dihydrate Azithromycin Dihydrate REMEDYREPACK INC. ANDA Current 71205-491 Azithromycin Dihydrate Azithromycin Dihydrate Proficient Rx LP ANDA Current 72189-090 AZITHROMYCIN DIHYDRATE AZITHROMYCIN DIHYDRATE DIRECT RX ANDA Current 72189-090 AZITHROMYCIN DIHYDRATE AZITHROMYCIN DIHYDRATE DIRECT RX ANDA Current 72789-063 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-063 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-063 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-066 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-066 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-066 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-066 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-066 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-066 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-066 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-169 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-169 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-169 Azithromycin Dihydrate Azithromycin Dihydrate PD-Rx Pharmaceuticals, Inc. ANDA Current 80425-0220 Azithromycin Dihydrate Azithromycin Dihydrate Advanced Rx Pharmacy of Tennessee, LLC ANDA Current