Application 021036

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RELENZA	ZANAMIVIR	POWDER;INHALATION	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021036-001	RELENZA	ZANAMIVIR	5MG	POWDER / INHALATION		RLD, RS	1999-07-26

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RELENZA	ZANAMIVIR	A-S Medication Solutions	b4e68930-4e6d-4d27-b1f0-abf60d12e28d	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021036 application number: NDA021036
RELENZA	ZANAMIVIR	GlaxoSmithKline LLC	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021036 application number: NDA021036 ndc (product): 0173-0681

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
0173-0681	RELENZA	zanamivir	GlaxoSmithKline LLC	NDA	Current
0173-0681	RELENZA	zanamivir	GlaxoSmithKline LLC	NDA	Current
0173-0681	RELENZA	zanamivir	GlaxoSmithKline LLC	NDA	Current
0173-0681	RELENZA	zanamivir	GlaxoSmithKline LLC	NDA	Current
0173-0681	RELENZA	zanamivir	GlaxoSmithKline LLC	NDA	Current
0173-0681	RELENZA	zanamivir	GlaxoSmithKline LLC	NDA	Current
0173-0681	RELENZA	zanamivir	GlaxoSmithKline LLC	NDA	Current
68258-3030	RELENZA	zanamivir	Dispensing Solutions Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75942	SUPPL	2023-10-25
75924	SUPPL	2023-10-25
69045	SUPPL	2021-10-21
69031	SUPPL	2021-10-20
54698	SUPPL	2018-06-27
54691	SUPPL	2018-06-27
21364	SUPPL	2014-01-16
14218	SUPPL	2011-12-23
26554	SUPPL	2011-12-22
4122	SUPPL	2010-12-15
35949	SUPPL	2010-12-10
4121	SUPPL	2010-05-07
26553	SUPPL	2010-03-29
35948	SUPPL	2010-03-26
26552	SUPPL	2009-10-16
26551	SUPPL	2009-10-16
26548	SUPPL	2009-10-16
4118	SUPPL	2009-10-16
4116	SUPPL	2009-10-16
35947	SUPPL	2008-10-09
4120	SUPPL	2008-10-07
35946	SUPPL	2008-02-25
4119	SUPPL	2008-02-25
26550	SUPPL	2007-09-11
14217	SUPPL	2007-09-11
4117	SUPPL	2007-03-15
26549	SUPPL	2006-04-05
14216	SUPPL	2006-04-03
26546	SUPPL	2004-06-15
21363	SUPPL	2004-04-12
35944	SUPPL	2003-10-07
35945	SUPPL	2003-08-15
26547	SUPPL	2003-08-15
14215	SUPPL	2001-04-27
35943	SUPPL	2000-04-26
26545	SUPPL	2000-04-26
21362	ORIG	1999-07-26
14214	ORIG	1999-07-26
4115	ORIG	1999-07-26