Application 073039

Type: ANDA
Sponsor: MYLAN

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 42.

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
A073039-001	SULINDAC	SULINDAC	200MG	TABLET / ORAL			1993-06-22
A073039-002	SULINDAC	SULINDAC	150MG	TABLET / ORAL			1993-06-22

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073039-001	SULINDAC	200MG	TABLET / ORAL	AB	1993-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A073039-002	SULINDAC	150MG	TABLET / ORAL	AB	1993-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073039-001	SULINDAC	200MG	TABLET / ORAL		1993-06-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A073039-002	SULINDAC	150MG	TABLET / ORAL		1993-06-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A073039-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A073039-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073039-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073039-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073039-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A073039-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073039-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A073039-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073039-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A073039-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073039-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A073039-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073039-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A073039-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073039-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A073039-002	AB	1	`ea99ee380514…`

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 · 10 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	Name fallback brand name: SULINDAC generic name: SULINDAC
SULINDAC	SULINDAC	A-S Medication Solutions	f4985b1b-7e2c-4911-897a-94c337794bab	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SULINDAC generic name: SULINDAC
SULINDAC	SULINDAC	PuraCap Laboratories LLC dba Blu Pharmaceuticals	0feabf47-8d0d-48c0-b263-43db4969f39e	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SULINDAC generic name: SULINDAC
SULINDAC	SULINDAC	PD-Rx Pharmaceuticals, Inc.	eb7acb87-6565-4524-a91a-02064ea8bd1a	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SULINDAC generic name: SULINDAC
SULINDAC	SULINDAC	PD-Rx Pharmaceuticals, Inc.	1fffe88d-50c8-45cf-ac7c-a62b665c89a8	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SULINDAC generic name: SULINDAC
Sulindac	SULINDAC	PD-Rx Pharmaceuticals, Inc.	68d4eeed-2501-494b-b979-502720de86c0	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sulindac generic name: SULINDAC
SULINDAC	SULINDAC	Epic Pharma, LLC	96c73bd2-4577-487d-a642-bd8f91e94c3a	2024-12-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SULINDAC generic name: SULINDAC
SULINDAC	SULINDAC	Sun Pharmaceutical Industries, Inc.	a47e4259-d44b-4b7b-b517-841cb6840982	2024-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SULINDAC generic name: SULINDAC
Sulindac	SULINDAC	Actavis Pharma, Inc.	d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4	2024-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sulindac generic name: SULINDAC
SULINDAC	SULINDAC	Proficient Rx LP	d94e8865-d151-4fb1-bacd-f4e43819e3c2	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SULINDAC generic name: SULINDAC

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0427	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0427	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0427	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0427	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0531	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0531	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0531	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0531	Sulindac	sulindac	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-667	Sulindac	sulindac	Mylan Institutional Inc.	ANDA	Current
51079-667	Sulindac	sulindac	Mylan Institutional Inc.	ANDA	Current
51079-667	Sulindac	sulindac	Mylan Institutional Inc.	ANDA	Current