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 12 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	Bryant Ranch Prepack	2bebda5e-227e-4a49-80e3-191cfc805295	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	203f96bb-ae63-475c-b7a6-03c0dbc43597	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	12cce748-a7de-4b1e-9603-b5c2ce12d531	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	2b7462e6-62dc-4b08-9fbf-5858e356a7a8	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	EXELAN PHARMACEUTICALS INC.	be25c19e-cbea-4f87-a581-9f0d350e5adf	2024-08-02	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	Padagis Israel Pharmaceuticals Ltd	3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b8	2024-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	005299ac-b6de-511f-e063-6294a90a29e0	2024-07-29	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	4b44ac98-225c-1739-e054-00144ff88e88	2024-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	abacf60f-0410-e6da-e053-2995a90a413c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	Amneal Pharmaceuticals LLC	78873f83-cea9-44d4-8ad4-8cb9257e5c7f	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	1d4d6370-2b45-fa6d-e063-6294a90a4a67	2024-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	NuCare Pharmaceuticals,Inc.	0326ea5b-3e1a-dee2-e063-6294a90a13b8	2024-07-09	Warnings	Name fallback brand name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	81e964ff-6622-4054-bf01-6ed6eef6778f	2024-07-06	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	898558e7-17f8-40cd-9dfc-67ddd64a5a42	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	KROGER COMPANY	15e59aac-a642-91e4-e063-6294a90a1175	2024-06-28	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	1be247b8-dafd-ddf9-e063-6294a90aa9e1	2024-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Curist Arthritis Relief	DICLOFENAC SODIUM	Little Pharma, Inc.	e638a98e-e6d7-36ed-e053-2995a90af2ca	2024-06-21	Warnings	Name fallback generic name: DICLOFENAC SODIUM
diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	8721da56-0f8a-5903-e053-2991aa0a61b5	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	8bda6135-c957-6b4e-e053-2995a90a0cb5	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	5d74488c-e092-415d-b19b-05318380d9b1	2024-06-10	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