Application 020692

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEREVENT	SALMETEROL XINAFOATE	POWDER;INHALATION	EQ 0.05MG BASE/INH	Yes	Yes

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
N020692-001	SEREVENT	SALMETEROL XINAFOATE	EQ 0.05MG BASE/INH	POWDER / INHALATION		RLD, RS	1997-09-19

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEREVENT DISKUS	SALMETEROL XINAFOATE	GlaxoSmithKline LLC	12d9728e-6b5c-4aee-bfb0-745e542ed2e4	2022-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020692 application number: NDA020692 ndc (product): 0173-0521

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0520	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0520	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0520	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0520	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0520	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0521	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0521	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0521	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0521	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0521	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0521	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
0173-0521	SEREVENT	salmeterol xinafoate	GlaxoSmithKline LLC	NDA	Current
68258-8961	SEREVENT	salmeterol xinafoate	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59412	SUPPL	2019-07-23
59402	SUPPL	2019-07-23
59401	SUPPL	2019-07-23
57074	SUPPL	2018-12-31
57011	SUPPL	2018-12-26
57010	SUPPL	2018-12-26
45585	SUPPL	2016-10-06
45475	SUPPL	2016-10-05
35149	SUPPL	2014-04-16
25527	SUPPL	2014-04-16
25526	SUPPL	2012-08-13
3094	SUPPL	2011-07-05
43666	SUPPL	2011-05-16
35148	SUPPL	2011-05-16
25525	SUPPL	2011-05-12
13216	SUPPL	2011-01-04
3092	SUPPL	2011-01-04
25524	SUPPL	2010-11-22
3093	SUPPL	2010-06-29
35147	SUPPL	2010-06-28
20828	SUPPL	2008-08-01
13215	SUPPL	2008-03-24
25523	SUPPL	2008-03-21
3090	SUPPL	2007-03-01
35146	SUPPL	2007-02-26
3091	SUPPL	2006-03-23
13214	SUPPL	2006-03-03
41558	ORIG	2005-12-06
23591	ORIG	2005-11-30
35145	SUPPL	2004-10-04
25522	SUPPL	2004-10-04
25521	SUPPL	2003-08-15
13213	SUPPL	2003-08-15
13212	SUPPL	2002-03-22
3089	SUPPL	2002-03-22
41559	SUPPL	1998-09-25
35144	SUPPL	1998-09-25
25520	SUPPL	1998-09-25
20827	SUPPL	1998-09-25
13211	SUPPL	1998-09-25
3088	SUPPL	1998-09-25