Application 202845

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIFLUNISAL	DIFLUNISAL	TABLET;ORAL	500MG	No	No
002	DIFLUNISAL	DIFLUNISAL	TABLET;ORAL	250MG	No	No
003	DIFLUNISAL	DIFLUNISAL	TABLET;ORAL	375MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202845-001	DIFLUNISAL	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08
A202845-002	DIFLUNISAL	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16
A202845-003	DIFLUNISAL	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202845-001	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 · 63 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	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`782e0a99824c…`

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	A202845-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202845-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202845-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202845-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202845-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202845-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202845-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202845-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202845-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202845-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202845-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202845-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202845-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202845-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202845-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202845-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202845-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202845-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202845-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202845-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202845-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202845-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202845-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202845-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202845-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202845-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202845-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202845-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202845-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202845-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202845-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202845-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202845-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
diflunisal	DIFLUNISAL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	666f89b4-fd81-420a-a390-eb1cd4014f61	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845 ndc (product): 14539-673
Dolobid	DIFLUNISAL	INA Pharmaceutics Inc	725234b2-0e23-45c3-a42d-eb4e62273f9b	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845
Diflunisal	DIFLUNISAL	Chartwell RX, LLC	2043bab8-87c9-45ce-88c7-383f0d4c4b64	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845

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
14539-673	diflunisal	diflunisal	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
14539-673	diflunisal	diflunisal	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
14539-673	diflunisal	diflunisal	Heritage Pharma Labs, Inc	ANDA	Current
14539-673	diflunisal	diflunisal	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
14539-673	diflunisal	diflunisal	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-673	diflunisal	diflunisal	Heritage Pharmaceuticals Inc.	ANDA	Current
50090-0450	DIFLUNISAL	DIFLUNISAL	A-S Medication Solutions	ANDA	Current
55700-559	DIFLUNISAL	DIFLUNISAL	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
64980-181	DIFLUNISAL	DIFLUNISAL	Rising Pharmaceuticals Inc.	ANDA	Current