Application 020763

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMERGE	NARATRIPTAN HYDROCHLORIDE	TABLET;ORAL	EQ 2.5MG BASE	Yes	Yes
002	AMERGE	NARATRIPTAN HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020763-001	AMERGE	NARATRIPTAN HYDROCHLORIDE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10
N020763-002	AMERGE	NARATRIPTAN HYDROCHLORIDE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020763-001	AMERGE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020763-002	AMERGE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL		RLD	1998-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL		RLD	1998-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL		RLD	1998-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL		RLD	1998-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL		RLD	1998-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL		RLD	1998-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL		RLD	1998-02-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL		RLD	1998-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL	AB	RLD	1998-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL	AB	RLD	1998-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL	AB	RLD	1998-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020763-001	AMERGE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, RS	1998-02-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020763-002	AMERGE	EQ 1MG BASE	TABLET / ORAL	AB	RLD	1998-02-10	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020763-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020763-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020763-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020763-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020763-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020763-002	AB	1	`cb3db0bc1861…`

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0561	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0561	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0561	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0561	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0562	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0562	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0562	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0562	AMERGE	naratriptan hydrochloride	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45995	SUPPL	2016-12-01
45972	SUPPL	2016-12-01
35295	SUPPL	2013-10-18
35292	SUPPL	2013-10-18
35291	SUPPL	2013-10-18
25732	SUPPL	2013-10-18
25728	SUPPL	2013-10-18
3283	SUPPL	2013-10-18
35294	SUPPL	2012-03-06
13361	SUPPL	2012-03-06
25731	SUPPL	2012-03-05
3284	SUPPL	2012-03-05
35293	SUPPL	2010-08-19
25730	SUPPL	2010-08-16
20920	ORIG	2004-05-27
23597	ORIG	2003-12-08
25729	SUPPL	2003-11-05
35290	ORIG	1998-02-10
25727	ORIG	1998-02-10