Home Applications 210616 Application 210616
Type ANDA
Sponsor CYCLE PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A210616-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210616-001 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 · 41 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 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 35573-450 Ketorolac Tromethamine Ketorolac Tromethamine Burel Pharmaceuticals, LLC ANDA Current 50090-6265 Ketorolac Tromethamine Ketorolac Tromethamine A-S Medication Solutions ANDA Current 63629-2488 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 63629-2488 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 63629-2488 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 63629-2488 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 63629-9285 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 68071-2443 Ketorolac Tromethamine Ketorolac Tromethamine NuCare Pharmaceuticals,Inc. ANDA Current 68071-2569 Ketorolac Tromethamine Ketorolac Tromethamine NuCare Pharmaceuticals,Inc. ANDA Current 69543-388 Ketorolac Tromethamine Ketorolac Tromethamine Virtus Pharmaceuticals, LLC ANDA Current 69543-388 Ketorolac Tromethamine Ketorolac Tromethamine Virtus Pharmaceuticals, LLC ANDA Current 69543-388 Ketorolac Tromethamine Ketorolac Tromethamine Virtus Pharmaceuticals, LLC ANDA Current 69543-388 Ketorolac Tromethamine Ketorolac Tromethamine Virtus Pharmaceuticals, LLC ANDA Current 69543-388 Ketorolac Tromethamine Ketorolac Tromethamine Virtus Pharmaceuticals, LLC ANDA Current 69543-388 Ketorolac Tromethamine Ketorolac Tromethamine Virtus Pharmaceuticals, LLC ANDA Current 70518-3308 Ketorolac Tromethamine Ketorolac Tromethamine REMEDYREPACK INC. ANDA Current 71335-1904 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 71335-1904 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 71335-1904 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 71335-1904 Ketorolac Tromethamine Ketorolac Tromethamine Bryant Ranch Prepack ANDA Current 72189-371 Ketorolac Tromethamine Ketorolac Tromethamine Direct_Rx ANDA Current 72189-371 Ketorolac Tromethamine Ketorolac Tromethamine Direct_Rx ANDA Current 72189-371 Ketorolac Tromethamine Ketorolac Tromethamine Direct_Rx ANDA Current