Home Applications 065488 Application 065488
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML No No 002 AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML No No
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 A065488-001 AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 A065488-002 AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15
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 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL AB 2015-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065488-001 AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065488-002 AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION / ORAL 2015-05-15 782e0a99824c…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43386-470 Azithromycin Azithromycin Lupin Pharmaceuticals,Inc. ANDA Current 43386-470 Azithromycin Azithromycin Lupin Pharmaceuticals,Inc. ANDA Current 43386-471 Azithromycin Azithromycin Lupin Pharmaceuticals,Inc. ANDA Current 43386-471 Azithromycin Azithromycin Lupin Pharmaceuticals,Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57399 SUPPL 2019-02-01 57398 SUPPL 2019-02-01