Application 090314

Type: ANDA
Sponsor: MYLAN ASI

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 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
A090314-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	SOLUTION / SUBCUTANEOUS			2010-06-10
A090314-002	SUMATRIPTAN SUCCINATE (AUTOINJECTOR)	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	SOLUTION / SUBCUTANEOUS	AB		2026-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090314-002	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 2 of 2 · 48 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
2023-05-13 08:27 UTC	2023-05	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090314-001	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2010-06-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090314-002	SUMATRIPTAN SUCCINATE (AUTOINJECTOR)	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	2026-01-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090314-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090314-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090314-002	AB	1	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	A090314-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090314-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090314-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090314-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090314-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090314-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090314-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090314-001	AP	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090314-002	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUMATRIPTAN	SUMATRIPTAN	Golden State Medical Supply, Inc.	4b4915d3-be7a-e5fa-e063-6294a90a7f98	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090314 application number: ANDA090314
SUMATRIPTAN	SUMATRIPTAN	Strides Pharma Science Limited	1909558d-8342-4af0-9487-eecdaac70070	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090314 application number: ANDA090314
sumatriptan	SUMATRIPTAN	ONESOURCE SPECIALTY PHARMA LIMITED	587e6bb5-a665-4396-814e-ce893a20290b	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090314 application number: ANDA090314

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-703	sumatriptan	sumatriptan	Sagent Pharmaceuticals	ANDA	Current
67457-879	sumatriptan	sumatriptan	Mylan Institutional LLC	ANDA	Current
67457-879	sumatriptan	sumatriptan	Mylan Institutional LLC	ANDA	Current
67457-879	sumatriptan	sumatriptan	Mylan Institutional LLC	ANDA	Current