Application 206116

Type: ANDA
Sponsor: AMNEAL PHARMS

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 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
A206116-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2016-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206116-001	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 · 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	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`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	A206116-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206116-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206116-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206116-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206116-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206116-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206116-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206116-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206116-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206116-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206116-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206116-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206116-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206116-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206116-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206116-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206116-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206116-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206116-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206116-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206116-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206116-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206116-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206116-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206116-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206116-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206116-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206116-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206116-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206116-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206116-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206116-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206116-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206116-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206116-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206116-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206116-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206116-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206116-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206116-001	AT	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC	Preferred Pharmaceuticals Inc.	937e9ba5-cdad-4e72-a77a-bad699e1b236	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116 ndc (product): 68788-7270
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	11e88ced-cdcf-4101-9297-c4c3dde9d089	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	0b4fd47f-903c-097b-e063-6394a90a49ab	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	PHOENIX RX LLC	41dab520-5651-a4c5-e063-6394a90a2962	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC SODIUM	Direct_Rx	0c41977f-8dad-1d26-e063-6294a90a9b22	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	a5b33bf7-8113-9c54-e053-2995a90a79d8	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116 ndc (product): 72189-075
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1896c84-b18a-d49d-e053-2995a90aaab3	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	Amneal Pharmaceuticals LLC	78873f83-cea9-44d4-8ad4-8cb9257e5c7f	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116 ndc (product): 65162-911
Diclofenac Sodium	DICLOFENAC	Proficient Rx LP	f4da38af-c5bd-4d4a-a6f3-c2933f223809	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	Bryant Ranch Prepack	e5f8284a-1aa9-4a36-a6ad-fa153c613f34	2023-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	A-S Medication Solutions	58178f0d-3960-48e3-91ba-150f691be241	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116 ndc (product): 50090-3316
Diclofenac Sodium	DICLOFENAC	Asclemed USA, Inc.	9df599de-6412-a94e-e053-2995a90a1741	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116 ndc (product): 76420-012

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-986	Diclofenac Sodium	Diclofenac	medsource pharmaceuticals	ANDA	Current
50090-3316	Diclofenac Sodium	Diclofenac	A-S Medication Solutions	ANDA	Current
50090-3316	Diclofenac Sodium	Diclofenac	A-S Medication Solutions	ANDA	Current
50090-3316	Diclofenac Sodium	Diclofenac	A-S Medication Solutions	ANDA	Current
50090-3316	Diclofenac Sodium	Diclofenac	A-S Medication Solutions	ANDA	Current
53149-4902	Diclofenac Sodium	Diclofenac	All Pharma, LLC	ANDA	Current
53149-4902	Diclofenac Sodium	Diclofenac	All Pharma, LLC	ANDA	Current
55700-735	Diclofenac Sodium	Diclofenac	Quality Care Products, LLC	ANDA	Current
55700-735	Diclofenac Sodium	Diclofenac	Quality Care Products, LLC	ANDA	Current
65162-911	Diclofenac Sodium	Diclofenac	Amneal Pharmaceuticals LLC	ANDA	Current
65162-911	Diclofenac Sodium	Diclofenac	Amneal Pharmaceuticals LLC	ANDA	Current
65162-911	Diclofenac Sodium	Diclofenac	Amneal Pharmaceuticals LLC	ANDA	Current
65162-911	Diclofenac Sodium	Diclofenac	Amneal Pharmaceuticals LLC	ANDA	Current
65162-911	Diclofenac Sodium	Diclofenac	Amneal Pharmaceuticals LLC	ANDA	Current
65162-911	Diclofenac Sodium	Diclofenac	Amneal Pharmaceuticals LLC	ANDA	Current
65162-911	Diclofenac Sodium	Diclofenac	Amneal Pharmaceuticals LLC	ANDA	Current
68788-7270	Diclofenac Sodium	Diclofenac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7270	Diclofenac Sodium	Diclofenac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7270	Diclofenac Sodium	Diclofenac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7270	Diclofenac Sodium	Diclofenac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7270	Diclofenac Sodium	Diclofenac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7270	Diclofenac Sodium	Diclofenac	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0871	Diclofenac Sodium	Diclofenac	REMEDYREPACK INC.	ANDA	Current
70518-0871	Diclofenac Sodium	Diclofenac	REMEDYREPACK INC.	ANDA	Current
70518-0871	Diclofenac Sodium	Diclofenac	REMEDYREPACK INC.	ANDA	Current
70518-0871	Diclofenac Sodium	Diclofenac	REMEDYREPACK INC.	ANDA	Current
70518-0871	Diclofenac Sodium	Diclofenac	REMEDYREPACK INC.	ANDA	Current
72189-075	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	ANDA	Current
72189-075	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	ANDA	Current
76420-012	Diclofenac Sodium	Diclofenac	Asclemed USA, Inc.	ANDA	Current
76420-012	Diclofenac Sodium	Diclofenac	Asclemed USA, Inc.	ANDA	Current