Home Applications 022165 Application 022165
Type NDA
Sponsor ASSERTIO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAMBIA DICLOFENAC POTASSIUM FOR SOLUTION;ORAL 50MG 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 N022165-001 CAMBIA DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022165-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product N022165-001 8927604 2026-06-16 U-436 2015-01-21 N022165-001 9827197 2026-06-16 Drug product 2017-12-05
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 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022165-001 CAMBIA 50MG FOR SOLUTION / ORAL AB RLD, RS 2009-06-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022165-001 8927604 2026-06-16 U-436 2015-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022165-001 8927604 2026-06-16 U-436 2015-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022165-001 8927604 2026-06-16 U-436 2015-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022165-001 8927604 2026-06-16 U-436 2015-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022165-001 8927604 2026-06-16 U-436 2015-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022165-001 8927604 2026-06-16 U-436 2015-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022165-001 8927604 2026-06-16 U-436 2015-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022165-001 8927604 2026-06-16 U-436 2015-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022165-001 8927604 2026-06-16 U-436 2015-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022165-001 7759394 2026-06-16 U-436 Drug substance, Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022165-001 8097651 2026-06-16 U-436 Drug substance, Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022165-001 8927604 2026-06-16 U-436 2015-01-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022165-001 9827197 2026-06-16 Drug product 2017-12-05 5bbf6a4d5a75…
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 · 2 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 13913-011 Cambia diclofenac potassium Depomed, Inc. NDA Current 13913-011 Cambia diclofenac potassium Assertio Therapeutics, Inc. NDA Current 13913-012 Cambia diclofenac potassium Depomed, Inc. NDA Current 13913-012 Cambia diclofenac potassium Assertio Therapeutics, Inc. NDA Current 13913-012 Cambia diclofenac potassium Assertio Therapeutics, Inc. NDA Current 50192-113 CAMBIA Diclofenac Potassium Nautilus Neurosciences, Inc. NDA Current 69315-506 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM Leading Pharma, LLC NDA AUTHORIZED GENERIC Current