Application 072711

Type: ANDA
Sponsor: EPIC PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULINDAC	SULINDAC	TABLET;ORAL	200MG	No	No
002	SULINDAC	SULINDAC	TABLET;ORAL	150MG	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
A072711-001	SULINDAC	SULINDAC	200MG	TABLET / ORAL	AB		1991-03-25
A072711-002	SULINDAC	SULINDAC	150MG	TABLET / ORAL	AB		1991-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072711-001	AB
A072711-002	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 · 45 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	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072711-002	SULINDAC	150MG	TABLET / ORAL	AB	1991-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072711-002	SULINDAC	150MG	TABLET / ORAL	AB	1991-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072711-002	SULINDAC	150MG	TABLET / ORAL	AB	1991-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072711-001	SULINDAC	200MG	TABLET / ORAL	AB	1991-03-25	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	A072711-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072711-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072711-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072711-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072711-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072711-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072711-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072711-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072711-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072711-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072711-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072711-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072711-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072711-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072711-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072711-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072711-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072711-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072711-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072711-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072711-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072711-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072711-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072711-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072711-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072711-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072711-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072711-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072711-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072711-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072711-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072711-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072711-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072711-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072711-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072711-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072711-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072711-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072711-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072711-001	AB	1	`3a93d1ddd44b…`

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
SULINDAC	SULINDAC	A-S Medication Solutions	6041acc2-5e8a-4d3c-bf50-7e9447748e2b	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072711 application number: ANDA072711 ndc (product): 50090-0529
SULINDAC	SULINDAC	PuraCap Laboratories LLC dba Blu Pharmaceuticals	0feabf47-8d0d-48c0-b263-43db4969f39e	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072711 application number: ANDA072711 ndc (product): 24658-771
SULINDAC	SULINDAC	Epic Pharma, LLC	96c73bd2-4577-487d-a642-bd8f91e94c3a	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072711 application number: ANDA072711 ndc (product): 42806-011
SULINDAC	SULINDAC	Proficient Rx LP	d94e8865-d151-4fb1-bacd-f4e43819e3c2	2022-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072711 application number: ANDA072711 ndc (product): 71205-648

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6216	Sulindac	Sulindac	Major Pharmaceuticals	ANDA	Current
0904-6216	Sulindac	Sulindac	Major Pharmaceuticals	ANDA	Current
0904-6217	Sulindac	Sulindac	Major Pharmaceuticals	ANDA	Current
0904-6217	Sulindac	Sulindac	Major Pharmaceuticals	ANDA	Current
24658-771	SULINDAC	SULINDAC	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
24658-771	SULINDAC	SULINDAC	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
24658-771	SULINDAC	SULINDAC	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
33261-100	Sulindac	Sulindac	Aidarex Pharmaceuticals LLC	ANDA	Current
42806-011	SULINDAC	SULINDAC	Epic Pharma, LLC	ANDA	Current
42806-011	SULINDAC	SULINDAC	Epic Pharma, LLC	ANDA	Current
50090-0529	SULINDAC	SULINDAC	A-S Medication Solutions	ANDA	Current
50090-4976	Sulindac	Sulindac	A-S Medication Solutions	ANDA	Current
50090-4976	Sulindac	Sulindac	A-S Medication Solutions	ANDA	Current
50090-4976	Sulindac	Sulindac	A-S Medication Solutions	ANDA	Current
53808-0814	Sulindac	Sulindac	State of Florida DOH Central Pharmacy	ANDA	Current
55700-682	SULINDAC	SULINDAC	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-682	SULINDAC	SULINDAC	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
71205-648	SULINDAC	SULINDAC	Proficient Rx LP	ANDA	Current
71335-0535	SULINDAC	SULINDAC	Bryant Ranch Prepack	ANDA	Current
71335-0535	SULINDAC	SULINDAC	Bryant Ranch Prepack	ANDA	Current