Application 204306

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	GEL;TOPICAL	1%	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
A204306-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2019-05-06

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	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204306-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204306-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204306-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204306-001	AB	1	`ea99ee380514…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	226da8a2-807d-4784-8d33-b434f3951a52	2026-08-12	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	09643e65-f301-4891-96f4-d78bf3621e23	2026-07-02	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	929f71ab-f0c8-4331-800d-ed4a172e647e	2026-01-14	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	37362eb4-db16-f4ad-e063-6394a90a42aa	2025-12-13	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurobindo Pharma Limited	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	2025-11-19	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	GERI-CARE PHARMACEUTICAL CORP	fc08e58c-6323-e667-e053-6394a90ab754	2025-04-21	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
DICLOFENAC SODIUM	DICLOFENAC SODIUM	INNOVUS PHARMACEUTICALS, INC.	ad9d2c28-21bc-4f81-9c90-cce6a96d976a	2025-03-25	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Harris Teeter	17ed520d-bfbe-4a33-e063-6394a90aa0f6	2024-08-30	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	81e964ff-6622-4054-bf01-6ed6eef6778f	2024-07-06	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	KROGER COMPANY	15e59aac-a642-91e4-e063-6294a90a1175	2024-06-28	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
AMAZON BASIC CARE ARTHRITIS PAIN	DICLOFENAC SODIUM	Amazon.com Services LLC	113e2f87-c408-3e44-e063-6394a90a0a7f	2024-05-17	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	2a599579-b2b0-4423-8e30-fe04bf815870	2023-08-11	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8750	Diclofenac Sodium	diclofenac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8750	Diclofenac Sodium	diclofenac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8750	Diclofenac Sodium	diclofenac	Mylan Pharmaceuticals Inc.	ANDA	Current
46122-711	Diclofenac Sodium	Diclofenac	Amerisource Bergen	ANDA	Current
57896-142	Diclofenac Sodium	Diclofenac	GERI-CARE PHARMACEUTICAL CORP	ANDA	Current
58602-601	Diclofenac Sodium	Diclofenac	Aurohealth LLC	ANDA	Current
58602-602	Diclofenac Sodium	Diclofenac	Aurohealth LLC	ANDA	Current
58602-603	Diclofenac Sodium	Diclofenac	Aurohealth LLC	ANDA	Current