Home Applications 022382 Application 022382
Type NDA
Sponsor ZYLA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SPRIX KETOROLAC TROMETHAMINE SPRAY, METERED;NASAL 15.75MG/SPRAY Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022382-001 SPRIX KETOROLAC TROMETHAMINE 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14
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 · 42 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 2026-08-18 06:07:40 2026-07 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022382-001 SPRIX 15.75MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2010-05-14 e64feba35796…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sprix KETOROLAC TROMETHAMINE Zyla Life Sciences US LLC 97005a1c-167e-4676-bae7-e49b38c36f9e 2024-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022382 application number: NDA022382 ndc (product): 69344-144
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66993-193 Ketorolac Tromethamine ketorolac tromethamine Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-193 Ketorolac Tromethamine ketorolac tromethamine Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-193 Ketorolac Tromethamine ketorolac tromethamine Prasco Laboratories NDA AUTHORIZED GENERIC Current 69344-144 Sprix ketorolac tromethamine Zyla Life Sciences US Inc. NDA Current 69344-144 Sprix ketorolac tromethamine Egalet US Inc. NDA Current 69344-144 Sprix ketorolac tromethamine Egalet US Inc. NDA Current 69344-144 Sprix ketorolac tromethamine Zyla Life Sciences US Inc. NDA Current 69344-144 Sprix ketorolac tromethamine Zyla Life Sciences US Inc. NDA Current 76519-1017 Sprix ketorolac tromethamine H.J. Harkins Company, Inc. NDA Current