Application 209903

Type: ANDA
Sponsor: CIPLA

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
A209903-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2018-08-03

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	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A209903-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209903-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209903-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209903-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209903-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209903-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209903-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209903-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209903-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209903-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209903-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	57c83158-f072-6fa2-e063-6394a90aee2c	2026-07-29	Warnings	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac sodium	DICLOFENAC SODIUM	Cipla USA Inc.	daf52f5a-1bb7-4808-ab98-483ab9e8cfa0	2025-03-11	Warnings	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	Quality Care Products, LLC	12e1f808-9f24-4f6d-b5bc-12ce0059ab7a	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	200c2800-a703-e138-e063-6394a90acc09	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	203f96bb-ae63-475c-b7a6-03c0dbc43597	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903 ndc (product): 50090-4030
Diclofenac Sodium	DICLOFENAC SODIUM	EXELAN PHARMACEUTICALS INC.	be25c19e-cbea-4f87-a581-9f0d350e5adf	2024-08-02	Warnings	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	51756947-e802-4b4d-883e-fd6f22e9a725	2023-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903 ndc (product): 50090-4020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-976	Diclofenac sodium	Diclofenac sodium	NorthStar RxLLC	ANDA	Current
16714-976	Diclofenac sodium	Diclofenac sodium	NorthStar RxLLC	ANDA	Current
50090-4020	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4020	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4020	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4021	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4030	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4030	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-4030	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-5075	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50090-5077	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
68788-7433	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7433	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7433	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7433	Diclofenac Sodium	Diclofenac Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
69097-524	Diclofenac Sodium	Diclofenac Sodium	Cipla USA Inc.	ANDA	Current
69097-524	Diclofenac Sodium	Diclofenac Sodium	Cipla USA Inc.	ANDA	Current
69097-524	Diclofenac Sodium	Diclofenac Sodium	Cipla USA Inc.	ANDA	Current
69097-524	Diclofenac Sodium	Diclofenac Sodium	Cipla USA Inc.	ANDA	Current
69097-524	Diclofenac Sodium	Diclofenac Sodium	Cipla USA Inc.	ANDA	Current
69097-524	Diclofenac Sodium	Diclofenac Sodium	Cipla USA Inc.	ANDA	Current
69097-524	Diclofenac Sodium	Diclofenac Sodium	Cipla USA Inc.	ANDA	Current
71335-1226	Diclofenac Sodium	Diclofenac Sodium	Bryant Ranch Prepack	ANDA	Current
76282-663	Diclofenac Sodium	Diclofenac Sodium	EXELAN PHARMACEUTICALS INC.	ANDA	Current
76282-663	Diclofenac Sodium	Diclofenac Sodium	EXELAN PHARMACEUTICALS INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79915	SUPPL	2024-10-21