Application 020080

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMITREX	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	Yes	Yes
002	IMITREX STATDOSE	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	Yes	Yes
003	IMITREX STATDOSE	SUMATRIPTAN SUCCINATE	INJECTABLE;SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	Yes	Yes

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

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	TE codes	RLD / RS	Approval date
N020080-001	IMITREX	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS		RLD	1992-12-28
N020080-002	IMITREX STATDOSE (AUTOINJECTOR)	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2006-02-01
N020080-003	IMITREX STATDOSE (AUTOINJECTOR)	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	1996-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020080-002	AB
N020080-003	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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1992-12-28	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	2006-02-01	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1992-12-28	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	2006-02-01	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	1992-12-28	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	2006-02-01	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020080-001	IMITREX	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / SUBCUTANEOUS		RLD	1992-12-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020080-002	IMITREX STATDOSE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	2006-02-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020080-003	IMITREX STATDOSE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AB	RLD, RS	1996-12-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020080-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020080-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020080-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020080-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020080-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020080-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020080-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020080-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020080-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020080-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020080-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020080-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020080-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020080-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020080-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020080-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020080-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020080-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020080-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020080-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020080-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020080-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020080-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020080-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020080-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020080-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020080-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020080-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020080-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020080-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020080-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020080-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020080-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020080-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020080-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020080-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020080-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020080-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020080-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020080-003	AB	1	`782e0a99824c…`

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
IMITREX	SUMATRIPTAN	GlaxoSmithKline LLC	fee7d073-0b99-48f2-7985-0d8cf970894b	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020080 application number: NDA020080 ndc (product): 0173-0478 ndc (product): 0173-0739 ndc (product): 0173-0479

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 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0449	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0449	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0173-0449	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0173-0478	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0478	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0478	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0173-0478	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0478	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0478	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0173-0479	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0479	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0479	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0173-0479	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0479	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0479	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0173-0739	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0739	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0739	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0173-0739	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0739	IMITREX	sumatriptan	GlaxoSmithKline LLC	NDA	Current
0173-0739	IMITREX	sumatriptan succinate	GlaxoSmithKline LLC	NDA	Current
0781-3169	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3169	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3169	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3169	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3169	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3170	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3170	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3170	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3170	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3170	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3172	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3172	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3172	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3172	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3172	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3173	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3173	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3173	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3173	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3173	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3174	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3174	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3174	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
0781-3174	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Sandoz Inc	NDA	Current
66993-083	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-083	SUMATRIPTAN	sumatriptan	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-083	SUMATRIPTAN	sumatriptan	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-083	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-084	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-084	SUMATRIPTAN	sumatriptan	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-084	SUMATRIPTAN	sumatriptan	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-084	SUMATRIPTAN SUCCINATE	sumatriptan succinate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
70518-2738	SUMATRIPTAN SUCCINATE	sumatriptan succinate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2738	SUMATRIPTAN SUCCINATE	sumatriptan succinate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84431	SUPPL	2025-12-17
84380	SUPPL	2025-12-10
69733	SUPPL	2021-12-21
69728	SUPPL	2021-12-21
67591	SUPPL	2021-05-25
66849	SUPPL	2021-03-24
54950	SUPPL	2018-07-23
54919	SUPPL	2018-07-19
50705	SUPPL	2017-12-15
50699	SUPPL	2017-12-15
34243	SUPPL	2015-11-25
21125	SUPPL	2015-11-20
12189	SUPPL	2015-06-12
1997	SUPPL	2015-06-12
34242	SUPPL	2012-10-04
34241	SUPPL	2012-10-04
21124	SUPPL	2012-10-04
21123	SUPPL	2012-10-04
12188	SUPPL	2012-10-04
12187	SUPPL	2012-10-04
1996	SUPPL	2012-10-04
1995	SUPPL	2012-10-04
34240	SUPPL	2010-07-31
1994	SUPPL	2010-07-28
20468	SUPPL	2007-07-24
44043	ORIG	2007-01-17
21122	SUPPL	2006-02-08
12186	SUPPL	2006-02-07
21120	SUPPL	2004-06-07
21121	SUPPL	2003-08-15
41141	SUPPL	1997-11-20