Application 076554

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	TABLET;ORAL	EQ 25MG BASE	No	No
002	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	TABLET;ORAL	EQ 50MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076554-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL			2009-08-10
A076554-002	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL			2009-08-10

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 · 88 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
2026-10-15 13:18:30	2026-09	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076554-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076554-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`4b0b4de00fa7…`

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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076554-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076554-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076554-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076554-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076554-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076554-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076554-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076554-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076554-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076554-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076554-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076554-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076554-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076554-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076554-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076554-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076554-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076554-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076554-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076554-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076554-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076554-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076554-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076554-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076554-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076554-002	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076554-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076554-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076554-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076554-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076554-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076554-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076554-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076554-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076554-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076554-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076554-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076554-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076554-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076554-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUMATRIPTAN	SUMATRIPTAN	Proficient Rx LP	5cba3661-9b16-416b-b0c0-bbb12549d48f	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076554 application number: ANDA076554 ndc (product): 63187-164

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
50436-4622	SUMATRIPTAN	SUMATRIPTAN	Unit Dose Services	ANDA	Current
50436-4622	SUMATRIPTAN	SUMATRIPTAN	Unit Dose Services	ANDA	Current
50436-4623	SUMATRIPTAN	SUMATRIPTAN	Unit Dose Services	ANDA	Current
63187-164	SUMATRIPTAN	SUMATRIPTAN	Proficient Rx LP	ANDA	Current
63187-164	SUMATRIPTAN	SUMATRIPTAN	Proficient Rx LP	ANDA	Current
63304-097	SUMATRIPTAN	SUMATRIPTAN	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-097	Sumatriptan	Sumatriptan	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
63304-098	SUMATRIPTAN	SUMATRIPTAN	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-098	Sumatriptan	Sumatriptan	SUN PHARMACEUTICAL INDUSTRIES, INC.	ANDA	Current
68788-9308	SUMATRIPTAN	SUMATRIPTAN	Preferred Pharmaceuticals	ANDA	Current
68788-9798	SUMATRIPTAN	SUMATRIPTAN	Preferred Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8924	ORIG	2009-08-14