Application 076561

Type: ANDA
Sponsor: AMICI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	TABLET;ORAL	50MG	No	No
002	CATAFLAM	DICLOFENAC POTASSIUM	TABLET;ORAL	25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076561-001	CATAFLAM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		2004-03-18
A076561-002	CATAFLAM	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076561-001	AB
A076561-002	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 · 74 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	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076561-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2004-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076561-001	CATAFLAM	50MG	TABLET / ORAL	AB	2004-03-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076561-002	CATAFLAM	25MG	TABLET / ORAL	AB	2021-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076561-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2004-03-18	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A076561-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076561-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076561-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076561-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076561-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076561-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076561-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076561-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076561-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076561-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076561-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076561-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076561-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076561-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076561-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076561-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076561-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076561-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076561-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076561-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076561-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076561-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076561-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076561-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076561-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076561-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076561-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076561-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076561-001	AB	1	`87673890dc5c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Golden State Medical Supply, Inc.	c2c79af6-f35e-5cdf-e053-2a95a90a4d63	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561 ndc (product): 51407-443
Diclofenac Potassium	DICLOFENAC POTASSIUM	Amici Pharma Inc.	f2908870-a517-491f-8771-4100d11b4b64	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561 ndc (product): 69292-550
LOFENA	DICLOFENAC POTASSIUM	Carwin Pharmaceutical Associates, LLC	49bd64cc-5edb-44f2-8e24-1249f6a76663	2024-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561 ndc (product): 15370-180
Diclofenac Potassium	DICLOFENAC POTASSIUM	Carwin Pharmaceutical Associates, LLC	bce95bb3-3097-4e7d-8d29-0870bb729212	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076561 application number: ANDA076561

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
15370-180	LOFENA	DICLOFENAC POTASSIUM	CARWIN PHARMACEUTICAL ASSOCIATES, LLC	ANDA	Current
51407-443	Diclofenac Potassium	diclofenac potassium	Golden State Medical Supply, Inc.	ANDA	Current
69292-550	Diclofenac Potassium	diclofenac potassium	Amici Pharmaceuticals LLC.	ANDA	Current
69292-550	Diclofenac Potassium	diclofenac potassium	Amici Pharmaceuticals LLC.	ANDA	Current
69292-550	Diclofenac Potassium	diclofenac potassium	Amici Pharmaceuticals LLC.	ANDA	Current
69292-550	Diclofenac Potassium	diclofenac potassium	Amici Pharmaceuticals LLC.	ANDA	Current
70934-906	Diclofenac Potassium	diclofenac potassium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
73684-150	CATAFLAM	diclofenac potassium	BLUCREST PHARMACEUTICALS, LLC	ANDA	Current
73684-150	CATAFLAM	diclofenac potassium	BLUCREST PHARMACEUTICALS, LLC	ANDA	Current