Application 202852

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	SOLUTION;TOPICAL	1.5%	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202852-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202852-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202852-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2014-11-24	`e64feba35796…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202852-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202852-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202852-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202852-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202852-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202852-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202852-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202852-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202852-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202852-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202852-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202852-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202852-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202852-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202852-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202852-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202852-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202852-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202852-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202852-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202852-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202852-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202852-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202852-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202852-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202852-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202852-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202852-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202852-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202852-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202852-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202852-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202852-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202852-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202852-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202852-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202852-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202852-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202852-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202852-001	AT	1	`e64feba35796…`

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 16 · 314 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	2a7019e9-e20f-4897-9b8e-942a7f2b34f6	2026-08-12	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	226da8a2-807d-4784-8d33-b434f3951a52	2026-08-12	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	681b6b25-4a28-44f2-8042-d5e01a502116	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	Care One (Retail Business Services, LLC.)	4484a332-aab1-46a9-aca8-159e7a09439f	2026-08-12	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	57c83158-f072-6fa2-e063-6394a90aee2c	2026-07-29	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	ddd2278b-70be-41ca-8a84-e3fe0f1a1561	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	CVS Pharmacy	591cc2ed-e667-4779-a426-8a2e6f873573	2026-07-22	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	HAWAII REPACK, INC	ea113a58-c7ed-4768-9777-93d9b166dfbe	2026-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM 1%	Sportpharm LLC	391d9d0b-74b7-4359-aea0-d3bb8c8d3cd1	2026-07-10	Warnings	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	63c00b50-06d3-4659-81cf-be4516429e81	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	6e6a6f98-5517-4f67-9a6a-71019ba2d773	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	71a823c4-9c88-474d-b525-276f9e7808aa	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	09643e65-f301-4891-96f4-d78bf3621e23	2026-07-02	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	30c7e4fd-30af-4d28-a6ef-7386ff83cfb8	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	dbb1489d-b690-4e53-905d-7fb07ad263b3	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEF	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	84978746-4ab5-456d-af63-5c86ab0a05f5	2026-06-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	10991fe6-fafd-49af-9684-83b447c19c67	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6980431d-4a2b-41e9-ae86-d46b4513f04b	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	ASCLEMED USA INC.	53e8ad44-ff67-d3bb-e063-6394a90a524d	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2140	Diclofenac sodium	Diclofenac sodium	Actavis Pharma, Inc.	ANDA	Current
55700-352	Diclofenac sodium	Diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current