Application 077871

Type: ANDA
Sponsor: PAR STERILE PRODUCTS

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 43.

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
A077871-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS			2009-07-09

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077871-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	2009-07-09	`f41ea6bd6efb…`

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 2 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	f6c907a3-9624-f893-e053-6294a90a31af	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	7628caf4-5272-4e42-e053-2a91aa0a2f24	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals, Inc.	2a96f37d-03f6-678c-e063-6394a90ae0c6	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Quality Care Products, LLC	5d1f3de0-684a-4092-be30-aa325ff20d04	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Quality Care Products, LLC	da77dfc4-551c-4e0e-a65e-cb478f193cd9	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Direct_Rx	284ee7ac-759e-b592-e063-6394a90a78ba	2024-12-02	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	b297a466-7d24-9ebd-e053-2a95a90af4d1	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	54c6f8f4-5466-3988-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	933f6575-a4c4-0f65-e053-2a95a90ab967	2024-06-19		Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	NuCare Pharmaceuticals,Inc.	85295be9-852d-4e21-e053-2991aa0a8a78	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Fresenius Kabi USA, LLC	b183c7ba-2cc6-4854-a9a6-71ccd3592586	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinate	SUMATRIPTAN SUCCINATE	A-S Medication Solutions	97016a59-3b49-4134-85aa-8c866f285601	2023-11-22	Warnings, Adverse reactions	Name fallback brand name: sumatriptan succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	NorthStar Rx LLC	38fd19bf-b7aa-812c-8a74-2414dfec45f4	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Proficient Rx LP	fe09fab6-b9e3-469c-9a38-bcc343dcc899	2023-01-01	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Asclemed USA, Inc.	77f9f135-e840-48f0-81e8-73e08433e768	2022-10-11	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Proficient Rx LP	abbd2168-1523-4eb6-a75c-dc4d7d1b1c9b	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Proficient Rx LP	1042b91c-715c-4e90-b9cc-d91a17f9f7cb	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinate	SUMATRIPTAN SUCCINATE	Proficient Rx LP	9f4d487a-c5f7-4707-976b-64e738c98d45	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: sumatriptan succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Dr. Reddy's Laboratories Limited	4e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b	2021-12-21	Warnings, Adverse reactions	Name fallback brand name: Sumatriptan Succinate generic name: SUMATRIPTAN SUCCINATE
Sumatriptan	SUMATRIPTAN SUCCINATE	Xellia Pharmaceuticals USA LLC	f42c6e00-e693-48f3-8e84-c3f139e1adf5	2021-11-18	Warnings, Adverse reactions	Name fallback generic name: SUMATRIPTAN SUCCINATE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-121	sumatriptan succinate	sumatriptan succinate	JHP Pharmaceuticals LLC	ANDA	Current