Application 078295

Type: ANDA
Sponsor: SUN PHARM INDS

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
003	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	TABLET;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A078295-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	2009-08-10
A078295-002	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	2009-08-10
A078295-003	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG 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 4 · 126 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	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL		2009-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL		2009-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL		2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL		2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL		2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL		2009-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078295-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078295-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2009-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078295-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2009-08-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078295-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078295-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078295-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078295-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078295-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078295-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078295-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078295-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078295-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078295-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078295-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078295-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078295-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078295-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078295-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078295-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078295-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078295-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078295-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078295-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078295-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078295-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078295-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078295-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078295-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078295-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078295-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078295-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078295-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078295-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078295-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078295-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078295-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078295-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078295-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078295-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078295-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078295-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078295-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078295-001	AB	1	`4b0b4de00fa7…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Sun Pharmaceutical Industries, Inc.	9485cc30-15e8-4b53-876d-db317145474b	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295 ndc (product): 62756-522 ndc (product): 62756-520 ndc (product): 62756-521
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	f6c95873-576d-a1c2-e053-6294a90a3ff9	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	f6c907a3-9624-f893-e053-6294a90a31af	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295
sumatriptan succinate	SUMATRIPTAN SUCCINATE	A-S Medication Solutions	97016a59-3b49-4134-85aa-8c866f285601	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295 ndc (product): 50090-5939
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	9f4d487a-c5f7-4707-976b-64e738c98d45	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295 ndc (product): 71205-274
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	d556563f-ad71-45c1-829a-cc11983bce0c	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078295 application number: ANDA078295 ndc (product): 71205-251

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-662	sumatriptan succinate	sumatriptan succinate	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-5939	sumatriptan succinate	sumatriptan succinate	A-S Medication Solutions	ANDA	Current
55700-092	sumatriptan succinate	sumatriptan succinate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-093	sumatriptan succinate	sumatriptan succinate	Lake Erie Medical DBA Qua	ANDA	Current
55700-093	sumatriptan succinate	sumatriptan succinate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-093	sumatriptan succinate	sumatriptan succinate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-093	sumatriptan succinate	sumatriptan succinate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-846	sumatriptan succinate	sumatriptan succinate	Quality Care Products, LLC	ANDA	Current
55700-846	sumatriptan succinate	sumatriptan succinate	Quality Care Products, LLC	ANDA	Current
62756-520	sumatriptan succinate	sumatriptan succinate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-520	sumatriptan succinate	sumatriptan succinate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-521	sumatriptan succinate	sumatriptan succinate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-521	sumatriptan succinate	sumatriptan succinate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-522	sumatriptan succinate	sumatriptan succinate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-522	sumatriptan succinate	sumatriptan succinate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
68071-4389	sumatriptan succinate	sumatriptan succinate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4389	sumatriptan succinate	sumatriptan succinate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-1658	sumatriptan succinate	sumatriptan succinate	Carilion Materials Management	ANDA	Current
68258-7114	sumatriptan succinate	sumatriptan succinate	Dispensing Solutions, Inc.	ANDA	Current
68788-7158	sumatriptan succinate	sumatriptan succinate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7158	sumatriptan succinate	sumatriptan succinate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7158	sumatriptan succinate	sumatriptan succinate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8205	sumatriptan succinate	sumatriptan succinate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1183	sumatriptan succinate	sumatriptan succinate	REMEDYREPACK INC.	ANDA	Current
70518-1183	sumatriptan succinate	sumatriptan succinate	REMEDYREPACK INC.	ANDA	Current
70518-1183	sumatriptan succinate	sumatriptan succinate	REMEDYREPACK INC.	ANDA	Current
70518-1183	sumatriptan succinate	sumatriptan succinate	REMEDYREPACK INC.	ANDA	Current
70518-1183	sumatriptan succinate	sumatriptan succinate	REMEDYREPACK INC.	ANDA	Current
70518-1183	sumatriptan succinate	sumatriptan succinate	REMEDYREPACK INC.	ANDA	Current
71205-251	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current
71205-251	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current
71205-251	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current
71205-274	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current
71205-274	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current
71205-274	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current
71205-274	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current
71205-725	sumatriptan succinate	sumatriptan succinate	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9139	ORIG	2009-08-14