Application 212506

Type: ANDA
Sponsor: ALEOR DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	SOLUTION;TOPICAL	2%	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
A212506-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212506-001	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.

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	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212506-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2022-11-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212506-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212506-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212506-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212506-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212506-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212506-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212506-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212506-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212506-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212506-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212506-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212506-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212506-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212506-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212506-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212506-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212506-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212506-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212506-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212506-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212506-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212506-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212506-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212506-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212506-001	AB	1	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	AvKARE	0416ce03-c345-9d9e-e063-6294a90ad940	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212506 application number: ANDA212506
Diclofenac sodium	DICLOFENAC SODIUM	Alembic Pharmaceuticals Limited	048ede6a-b7cd-4100-8979-519bd44906c8	2025-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212506 application number: ANDA212506
Diclofenac sodium	DICLOFENAC SODIUM	Alembic Pharmaceuticals Inc.	02e90e33-384f-4e29-b508-2503def22214	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212506 application number: ANDA212506 ndc (product): 62332-487
Diclofenac sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	fc0e1950-d76f-75bc-e053-6294a90a8c12	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212506 application number: ANDA212506
Diclofenac sodium	DICLOFENAC SODIUM	Quality Care Products, LLC	3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212506 application number: ANDA212506

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62332-487	Diclofenac sodium	Diclofenac sodium	Alembic Pharmaceuticals, Inc.	ANDA	Current