Application 071795

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULINDAC	SULINDAC	TABLET;ORAL	200MG	No	Yes

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
A071795-001	SULINDAC	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071795-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071795-001	SULINDAC	200MG	TABLET / ORAL	AB	RS	1990-04-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A071795-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071795-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071795-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071795-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071795-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071795-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071795-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071795-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071795-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071795-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071795-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071795-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071795-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071795-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071795-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071795-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071795-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071795-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071795-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071795-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071795-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071795-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071795-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071795-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071795-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071795-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071795-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071795-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071795-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071795-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071795-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071795-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071795-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071795-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071795-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071795-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071795-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071795-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071795-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071795-001	AB	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulindac	SULINDAC	PD-Rx Pharmaceuticals, Inc.	68d4eeed-2501-494b-b979-502720de86c0	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071795 application number: ANDA071795 ndc (product): 55289-930
Sulindac	SULINDAC	Actavis Pharma, Inc.	d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071795 application number: ANDA071795 ndc (product): 0591-5660

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5660	Sulindac	Sulindac	Actavis Pharma, Inc.	ANDA	Current
0591-5660	Sulindac	Sulindac	Actavis Pharma, Inc.	ANDA	Current
0591-5660	Sulindac	Sulindac	Actavis Pharma, Inc.	ANDA	Current
0591-5660	Sulindac	Sulindac	Actavis Pharma, Inc.	ANDA	Current
0591-5660	Sulindac	Sulindac	Actavis Pharma, Inc.	ANDA	Current
50090-0528	Sulindac	Sulindac	A-S Medication Solutions	ANDA	Current
52959-195	Sulindac	Sulindac	H.J. Harkins Company, Inc.	ANDA	Current
55289-930	Sulindac	Sulindac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-930	Sulindac	Sulindac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-930	Sulindac	Sulindac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-930	Sulindac	Sulindac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-930	Sulindac	Sulindac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63629-3208	Sulindac	Sulindac	Bryant Ranch Prepack	ANDA	Current
63629-3208	Sulindac	Sulindac	Bryant Ranch Prepack	ANDA	Current
63629-3208	Sulindac	Sulindac	Bryant Ranch Prepack	ANDA	Current
68151-2871	Sulindac	Sulindac	Carilion Materials Management	ANDA	Current
68151-2872	Sulindac	Sulindac	Carilion Materials Management	ANDA	Current
70934-550	Sulindac	Sulindac	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current