Application 078553

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	0.1%	No	No

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
A078553-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078553-001	AT

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078553-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2007-12-28	`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	A078553-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078553-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078553-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078553-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078553-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078553-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078553-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078553-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078553-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078553-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078553-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078553-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078553-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078553-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078553-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078553-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078553-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078553-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078553-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078553-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078553-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078553-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078553-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078553-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078553-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078553-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078553-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078553-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078553-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078553-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078553-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078553-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078553-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078553-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078553-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078553-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078553-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078553-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078553-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078553-001	AT	1	`f41ea6bd6efb…`

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 13 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	629b77cf-f825-8640-e053-2991aa0a10a8	2024-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	7bf19e84-4f75-4d5c-9927-99220c58b572	2024-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Medsource Pharmaceuticals	1495ed53-0489-a465-e063-6394a90af68d	2024-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Lupin Pharmaceuticals,Inc.	7559928e-eeb8-47e8-8a55-d59e06bbc737	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Simple Diagnostics	13925cd5-e121-80d2-e063-6394a90af9a9	2024-03-19	Warnings	Name fallback brand name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	f104f8fb-066f-4bbf-8894-3b3ed1b8266d	2024-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	df5bb0e7-a3a9-4650-aae7-9a11ce615d5d	2024-02-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Padagis Israel Pharmaceuticals Ltd	17bd62a8-b697-48cc-b988-aac3c19c6dc5	2024-01-22	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	7c3d8d33-8849-44df-bb57-57d32b96a0e4	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	bced0ef0-085a-40db-9678-2bc6eb77d456	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC	Amneal Pharmaceuticals NY LLC	1084e0c3-6d75-4090-84dc-02a18e0299b9	2023-12-29	Warnings	Name fallback brand name: Diclofenac sodium
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	A-S Medication Solutions	828b5de2-77a7-4893-ab47-dffc8ea73693	2023-12-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	50efc183-dd3e-4eb7-ba5c-c42fd76e0b65	2023-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Proficient Rx LP	f19bf286-f4dd-4491-90c3-9f8713071903	2023-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	CVS Pharmacy	e9ccaf95-582b-4d4d-938f-7577eaa8dffb	2023-11-27	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	e6a1ff58-a541-46f8-9663-eed53b7cf392	2023-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	51756947-e802-4b4d-883e-fd6f22e9a725	2023-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	9df87100-acf5-4b46-93b4-067b470136bd	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	CVS PHARMACY, INC	4808015d-cfee-4f4d-a84b-82099f0b4868	2023-10-04	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	0379c918-1717-40ab-81cc-268116950fd5	2023-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-101	Diclofenac Sodium	Diclofenac Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current