Application 090495

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	No	No

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
A090495-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB		2014-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090495-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090495-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2014-01-29	`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	A090495-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090495-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090495-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090495-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090495-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090495-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090495-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090495-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090495-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090495-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090495-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090495-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090495-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090495-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090495-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090495-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090495-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090495-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090495-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090495-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090495-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090495-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090495-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090495-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090495-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090495-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090495-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090495-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090495-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090495-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090495-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090495-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090495-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090495-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090495-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090495-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090495-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090495-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090495-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090495-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Sportpharm LLC	7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090495 application number: ANDA090495
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Dr. Reddys Laboratories Inc.,	8fef1176-7a38-eca3-22ca-83efe5ca6620	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090495 application number: ANDA090495
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	NorthStar Rx LLC	38fd19bf-b7aa-812c-8a74-2414dfec45f4	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090495 application number: ANDA090495
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Dr. Reddy's Laboratories Limited	4e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b	2021-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090495 application number: ANDA090495 ndc (product): 55111-693

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-040	Sumatriptan Succinate	Sumatriptan Succinate	NorthStar Rx LLC	ANDA	Current
16714-040	Sumatriptan Succinate	Sumatriptan Succinate	NorthStar Rx LLC	ANDA	Current
55111-693	Sumatriptan Succinate	Sumatriptan Succinate	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-693	Sumatriptan Succinate	Sumatriptan Succinate	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-693	Sumatriptan Succinate	Sumatriptan Succinate	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-693	Sumatriptan Succinate	Sumatriptan Succinate	Dr. Reddy's Laboratories Limited	ANDA	Current
70518-3179	Sumatriptan Succinate	Sumatriptan Succinate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22710	ORIG	2016-07-29