Application 022202

Type: NDA
Sponsor: ASSERTIO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZIPSOR	DICLOFENAC POTASSIUM	CAPSULE;ORAL	25MG	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
N022202-001	ZIPSOR	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022202-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022202-001	7662858	2029-02-24	U-1035
N022202-001	7884095	2029-02-24	U-1111	2011-02-22
N022202-001	7939518	2029-02-24	U-980	2011-05-19
N022202-001	8110606	2029-02-24	U-980	2012-02-13
N022202-001	8623920	2029-02-24	U-1482	2014-02-05
N022202-001	9561200	2029-02-24	U-1482	2017-02-14

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 · 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	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022202-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022202-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022202-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022202-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022202-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022202-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022202-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022202-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022202-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022202-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022202-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022202-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022202-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022202-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022202-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022202-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022202-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022202-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022202-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022202-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022202-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022202-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022202-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022202-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022202-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022202-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022202-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022202-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022202-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022202-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022202-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022202-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022202-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022202-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022202-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022202-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022202-001	AB	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022202-001	7662858	2029-02-24	U-1035		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022202-001	8623920	2029-02-24	U-1482	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022202-001	9561200	2029-02-24	U-1482	2017-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022202-001	7662858	2029-02-24	U-1035		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022202-001	8623920	2029-02-24	U-1482	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022202-001	9561200	2029-02-24	U-1482	2017-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022202-001	7662858	2029-02-24	U-1035		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022202-001	8623920	2029-02-24	U-1482	2014-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022202-001	9561200	2029-02-24	U-1482	2017-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	7662858	2029-02-24	U-1035		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	8623920	2029-02-24	U-1482	2014-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022202-001	9561200	2029-02-24	U-1482	2017-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022202-001	7662858	2029-02-24	U-1035		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022202-001	8623920	2029-02-24	U-1482	2014-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022202-001	9561200	2029-02-24	U-1482	2017-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	7662858	2029-02-24	U-1035		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	8623920	2029-02-24	U-1482	2014-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022202-001	9561200	2029-02-24	U-1482	2017-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	7662858	2029-02-24	U-1035		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022202-001	NPP	2024-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022202-001	NPP	2024-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022202-001	NPP	2024-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022202-001	NPP	2024-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022202-001	NPP	2024-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022202-001	NPP	2024-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022202-001	NPP	2024-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022202-001	NPP	2024-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022202-001	NPP	2024-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022202-001	NPP	2024-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022202-001	NPP	2024-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022202-001	NPP	2024-05-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022202-001	NPP	2024-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022202-001	NPP	2024-05-25	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022202-001	NPP	2024-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022202-001	NPP	2024-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022202-001	NPP	2024-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022202-001	NPP	2024-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022202-001	NPP	2024-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022202-001	NPP	2024-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022202-001	NPP	2024-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022202-001	NPP	2024-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022202-001	NPP	2024-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022202-001	NPP	2024-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022202-001	NPP	2024-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022202-001	NPP	2024-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022202-001	NPP	2024-05-25	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIPSOR	DICLOFENAC POTASSIUM	Assertio Specialty Pharmaceuticals LLC	ed2a8868-78eb-47b8-8f46-0f70e2891e07	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022202 application number: NDA022202
ZIPSOR	DICLOFENAC POTASSIUM	Assertio Therapeutics, Inc.	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	2025-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022202 application number: NDA022202 ndc (product): 13913-008
Diclofenac Potassium	DICLOFENAC POTASSIUM	Leading Pharma, LLC	698690a7-4978-4457-b123-0a670bbab481	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022202 application number: NDA022202 ndc (product): 69315-275
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	69ab6f91-5770-480c-8bd1-8c1f1f8bfdb5	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022202 application number: NDA022202

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13913-008	ZIPSOR	diclofenac potassium	Depomed, Inc.	NDA	Current
13913-008	ZIPSOR	diclofenac potassium	Assertio Therapeutics, Inc.	NDA	Current
13913-008	ZIPSOR	diclofenac potassium	Depomed, Inc.	NDA	Current
13913-008	ZIPSOR	diclofenac potassium	Assertio Therapeutics, Inc.	NDA	Current
69315-275	Diclofenac Potassium	Diclofenac Potassium	Leading Pharma, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80389	SUPPL	2024-11-25
80388	SUPPL	2024-11-25
80307	SUPPL	2024-11-22
67607	SUPPL	2021-05-27
67606	SUPPL	2021-05-27
67595	SUPPL	2021-05-26
67594	SUPPL	2021-05-26
38377	SUPPL	2016-05-11
7042	SUPPL	2016-05-11
29399	SUPPL	2011-05-06
7041	SUPPL	2011-05-06
43836	ORIG	2011-02-15
44699	ORIG	2010-04-21
42448	ORIG	2010-04-21
29398	ORIG	2009-06-23
17079	ORIG	2009-06-22