Home Applications 019700 Application 019700
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACULAR KETOROLAC TROMETHAMINE 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 N019700-001 ACULAR KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019700-001 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 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 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 N019700-001 AT 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019700-001 AT 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019700-001 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-2181 Acular Ketorolac Tromethamine Allergan, Inc. NDA Current 0023-2181 Acular Ketorolac Tromethamine Allergan, Inc. NDA Current 0023-2181 Acular Ketorolac Tromethamine Allergan, Inc. NDA Current 21695-463 ACULAR KETOROLAC TROMETHAMINE Rebel Distributors Corp. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 83402 SUPPL 2025-09-19 83389 SUPPL 2025-09-19 11641 SUPPL 2012-06-18 1517 SUPPL 2012-06-18 20299 SUPPL 2009-01-12 33877 SUPPL 2005-03-11 19108 SUPPL 2005-03-11 11640 SUPPL 2005-03-11 1516 SUPPL 2005-03-11 11639 SUPPL 2003-06-16 33876 SUPPL 2002-02-08 19107 SUPPL 2002-02-08