Application 208301

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	GEL;TOPICAL	3%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208301-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208301-001	AB

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208301-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208301-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208301-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208301-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208301-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208301-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208301-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208301-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208301-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208301-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208301-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208301-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208301-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208301-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208301-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208301-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208301-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208301-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208301-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208301-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208301-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208301-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208301-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208301-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208301-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208301-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208301-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208301-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208301-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208301-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208301-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208301-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208301-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208301-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208301-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208301-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208301-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208301-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208301-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208301-001	AB	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	HAWAII REPACK, INC	ea113a58-c7ed-4768-9777-93d9b166dfbe	2026-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	96f8c42c-db34-43b0-a891-33dd8e39e74f	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301 ndc (product): 70518-3315
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	5d0a4b41-afbf-45e7-bb1c-587d72314ee0	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301 ndc (product): 68788-9435
Diclofenac Sodium Gel	DICLOFENAC SODIUM GEL	Direct_Rx	e82e4d34-bdaa-b950-e053-2995a90a29f1	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301 ndc (product): 72189-379
DICLOFENAC SODIUM	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	06862cf2-9537-6661-e063-6294a90a2084	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	GLENMARK PHARMACEUTICALS INC., USA	dab3ae60-0135-43b3-a1d0-8752720af82a	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301 ndc (product): 68462-355
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1892aae-7267-3b4c-e053-2995a90a8802	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Proficient Rx LP	f19bf286-f4dd-4491-90c3-9f8713071903	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Asclemed USA, Inc.	57d8513a-820a-46c5-b0c8-5aa1811b0e88	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301 ndc (product): 76420-132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-0355	DICLOFENAC SODIUM	diclofenac sodium	Unit Dose Services	ANDA	Current
53149-4901	DICLOFENAC SODIUM	diclofenac sodium	All Pharma, LLC	ANDA	Current
53149-4901	DICLOFENAC SODIUM	diclofenac sodium	All Pharma, LLC	ANDA	Current
55700-511	DICLOFENAC SODIUM	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-511	DICLOFENAC SODIUM	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-511	DICLOFENAC SODIUM	diclofenac sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-095	DICLOFENAC SODIUM	diclofenac sodium	St. Mary's Medical Park Pharmacy	ANDA	Current
68462-355	DICLOFENAC SODIUM	diclofenac sodium	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-355	DICLOFENAC SODIUM	diclofenac sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-355	DICLOFENAC SODIUM	diclofenac sodium	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-355	DICLOFENAC SODIUM	diclofenac sodium	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-9435	DICLOFENAC SODIUM	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9435	DICLOFENAC SODIUM	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9435	DICLOFENAC SODIUM	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9435	DICLOFENAC SODIUM	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9435	DICLOFENAC SODIUM	diclofenac sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3315	DICLOFENAC SODIUM	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
70518-3315	DICLOFENAC SODIUM	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
70518-3315	DICLOFENAC SODIUM	diclofenac sodium	REMEDYREPACK INC.	ANDA	Current
72189-379	Diclofenac Sodium Gel	Diclofenac Sodium Gel	Direct_Rx	ANDA	Current
72189-379	Diclofenac Sodium Gel	Diclofenac Sodium Gel	Direct_Rx	ANDA	Current
76420-132	DICLOFENAC SODIUM	diclofenac sodium	Asclemed USA, Inc.	ANDA	Current