Home Applications 022548 Application 022548
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZYMAXID GATIFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.5% 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 N022548-001 ZYMAXID GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022548-001 AT
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 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 N022548-001 AT 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022548-001 AT 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022548-001 AT 1 a50c72e98297…
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.
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-3615 ZYMAXID gatifloxacin Allergan, Inc. NDA Current 0023-3615 ZYMAXID gatifloxacin Allergan, Inc. NDA Current 0023-3615 ZYMAXID gatifloxacin Allergan, Inc. NDA Current 60758-615 gatifloxacin gatifloxacin Pacific Pharma NDA AUTHORIZED Current 60758-615 gatifloxacin gatifloxacin Pacific Pharma, Inc. NDA AUTHORIZED GENERIC Current 60758-615 gatifloxacin gatifloxacin Pacific Pharma, Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 73161 SUPPL 2023-01-17 45279 SUPPL 2016-09-12 45267 SUPPL 2016-09-08 24336 ORIG 2011-02-17 42556 ORIG 2010-12-08 38834 ORIG 2010-05-28 7525 ORIG 2010-05-21 53284 ORIG 1900-01-01 53283 ORIG 1900-01-01 53282 ORIG 1900-01-01