Application 022165

Type
NDA
Sponsor
ASSERTIO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAMBIADICLOFENAC POTASSIUMFOR SOLUTION;ORAL50MGYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022165-001CAMBIADICLOFENAC POTASSIUM50MGFOR SOLUTION / ORALABRLD, RS2009-06-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N022165-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022165-00177593942026-06-16U-436Drug substance, Drug product
N022165-00180976512026-06-16U-436Drug substance, Drug product
N022165-00189276042026-06-16U-4362015-01-21
N022165-00198271972026-06-16Drug product2017-12-05

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-173f01610625f2…
2019-09-15 20:21 UTC2019-09N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022165-001CAMBIA50MGFOR SOLUTION / ORALABRLD, RS2009-06-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022165-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022165-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022165-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022165-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022165-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022165-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022165-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022165-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022165-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022165-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022165-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022165-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022165-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022165-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022165-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022165-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022165-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022165-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022165-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022165-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022165-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022165-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022165-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022165-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022165-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022165-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022165-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022165-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022165-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022165-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022165-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022165-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022165-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022165-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022165-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022165-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022165-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022165-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022165-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022165-001AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022165-00177593942026-06-16U-436Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022165-00180976512026-06-16U-436Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022165-00189276042026-06-16U-4362015-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022165-00198271972026-06-16Drug product2017-12-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022165-00177593942026-06-16U-436Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022165-00180976512026-06-16U-436Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022165-00189276042026-06-16U-4362015-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022165-00198271972026-06-16Drug product2017-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022165-00177593942026-06-16U-436Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022165-00180976512026-06-16U-436Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022165-00189276042026-06-16U-4362015-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022165-00198271972026-06-16Drug product2017-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022165-00177593942026-06-16U-436Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022165-00180976512026-06-16U-436Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022165-00189276042026-06-16U-4362015-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022165-00198271972026-06-16Drug product2017-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022165-00177593942026-06-16U-436Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022165-00180976512026-06-16U-436Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022165-00189276042026-06-16U-4362015-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022165-00198271972026-06-16Drug product2017-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022165-00177593942026-06-16U-436Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022165-00180976512026-06-16U-436Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022165-00189276042026-06-16U-4362015-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022165-00198271972026-06-16Drug product2017-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022165-00177593942026-06-16U-436Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022165-00180976512026-06-16U-436Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022165-00189276042026-06-16U-4362015-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022165-00198271972026-06-16Drug product2017-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022165-00177593942026-06-16U-436Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022165-00180976512026-06-16U-436Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022165-00189276042026-06-16U-4362015-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022165-00198271972026-06-16Drug product2017-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022165-00177593942026-06-16U-436Drug substance, Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022165-00180976512026-06-16U-436Drug substance, Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022165-00189276042026-06-16U-4362015-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022165-00198271972026-06-16Drug product2017-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022165-00177593942026-06-16U-436Drug substance, Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022165-00180976512026-06-16U-436Drug substance, Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022165-00189276042026-06-16U-4362015-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022165-00198271972026-06-16Drug product2017-12-05d8e5a09893c0…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CambiaDICLOFENAC POTASSIUMAssertio Therapeutics, Inc.d249ced1-4ca0-4f57-adcb-23440f58f6592024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022165
application number: NDA022165
ndc (product): 13913-012
DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMLeading Pharma, LLC9dd418b2-4b0e-498c-b453-f580c69ddc6d2024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022165
application number: NDA022165
ndc (product): 69315-506

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13913-011Cambiadiclofenac potassiumDepomed, Inc.NDACurrent
13913-011Cambiadiclofenac potassiumAssertio Therapeutics, Inc.NDACurrent
13913-012Cambiadiclofenac potassiumDepomed, Inc.NDACurrent
13913-012Cambiadiclofenac potassiumAssertio Therapeutics, Inc.NDACurrent
13913-012Cambiadiclofenac potassiumAssertio Therapeutics, Inc.NDACurrent
50192-113CAMBIADiclofenac PotassiumNautilus Neurosciences, Inc.NDACurrent
69315-506DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMLeading Pharma, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80403SUPPL 2024-11-25
80402SUPPL 2024-11-25
80306SUPPL 2024-11-22
78236SUPPL 2024-04-24
78235SUPPL 2024-04-24
67346SUPPL2021-05-03
67345SUPPL2021-05-03
67344SUPPL2021-05-03
67272SUPPL2021-04-30
67271SUPPL2021-04-30
47693SUPPL2017-03-24
47631SUPPL2017-03-22
47629SUPPL2017-03-21
38329SUPPL2016-05-11
6995SUPPL2016-05-11
29347SUPPL2011-07-25
44689ORIG2010-05-27
42435SUPPL2010-05-27
24252SUPPL2010-05-27
21951ORIG2010-05-27
43829SUPPL2009-11-16
29346ORIG2009-07-23
6994SUPPL2009-07-23
38328SUPPL2009-06-22
38327ORIG2009-06-22