Application 020762

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NASONEX	MOMETASONE FUROATE	SPRAY, METERED;NASAL	0.05MG/SPRAY	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
N020762-001	NASONEX	MOMETASONE FUROATE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD	1997-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD	1997-10-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020762-001	NASONEX	EQ 0.05MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD	1997-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD	1997-10-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020762-001	NASONEX	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020762-001	NASONEX	EQ 0.05MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020762-001	NASONEX	EQ 0.05MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020762-001	NASONEX	EQ 0.05MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-10-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020762-001	NASONEX	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	1997-10-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020762-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020762-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020762-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020762-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020762-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020762-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020762-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020762-001	AB	1	`ea99ee380514…`

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rugby mometasone furoate nasal	MOMETASONE FUROATE	Rugby Laboratories	b4c43535-ad22-44c2-b04f-df4348a6c485	2025-08-06	Warnings	Name fallback generic name: MOMETASONE FUROATE
MOMETASONE FUROATE	MOMETASONE FUROATE	Golden State Medical Supply, Inc.	e30ca373-d9c0-4cad-b5c3-3be9c299dddc	2025-07-10	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	a12fef6b-681e-4f80-8bcd-3f01733f1a67	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Sun Pharmaceutical Industries, Inc.	ce61920d-65df-4423-925d-091e624ea32e	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
MOMETASONE FUROATE	MOMETASONE FUROATE	Aurohealth LLC	48ba8c52-73b6-4ee9-ba13-756a645a9183	2024-11-25	Warnings	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	43a91066-1d85-4f67-9856-a11c1bb2b22b	2024-11-20	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	6c7d8133-b71e-4290-bec1-53ff0232998a	2024-08-30	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Childrens Nasonex	MOMETASONE FUROATE	L. Perrigo Company	e15d055e-9a25-46b4-8724-3609cf2dc062	2024-08-28	Warnings	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	45c9512b-9463-4684-bfdb-742644d77cc3	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Proficient Rx LP	2bf06b19-4ed7-41a3-b6fc-29713c41965c	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Cosette Pharmaceuticals, Inc.	f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d92	2023-11-29	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Cosette Pharmaceuticals, Inc.	f5b30e5e-b067-e28c-b7c5-aa58f4c57f09	2023-11-29	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	c3053a64-9044-496e-9005-12b4440d46e8	2023-10-20	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	d15edb8b-c8b2-4023-992e-f79cefa2d1e8	2023-08-16	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	a6055a9c-e19c-48ad-a743-c0a7f7366cdd	2023-07-18	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	5f1f2136-9e10-4d43-bb35-ed285c744fe4	2023-07-18	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	7296b4a2-f180-4887-a8e0-029f81aec566	2023-04-21	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	A-S Medication Solutions	9fe65193-b4d8-480b-89b3-178cd1b20713	2023-02-15	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Sinuva	MOMETASONE FUROATE	Intersect ENT, Inc.	e33c1b23-cdc6-4f64-94ba-24b0b42c09bf	2023-01-26	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Proficient Rx LP	47a60763-671e-413b-b962-f7f11ba2f4d7	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-1288	NASONEX	Mometasone furoate monohydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1288	NASONEX	Mometasone furoate monohydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1288	NASONEX	Mometasone furoate monohydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1288	NASONEX	Mometasone furoate monohydrate	Merck Sharp & Dohme Corp.	NDA	Current
0781-6355	Mometasone Furoate Monohydrate	Mometasone Furoate Monohydrate	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-6355	Mometasone Furoate Monohydrate	Mometasone Furoate Monohydrate	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-6355	Mometasone Furoate Monohydrate	Mometasone Furoate Monohydrate	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-6355	Mometasone Furoate Monohydrate	Mometasone Furoate Monohydrate	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-6355	Mometasone Furoate Monohydrate	Mometasone Furoate Monohydrate	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
50090-0620	NASONEX	Mometasone furoate monohydrate	A-S Medication Solutions	NDA	Current
78206-144	NASONEX	Mometasone furoate monohydrate	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71479	SUPPL	2022-06-29
71476	SUPPL	2022-06-29
64553	SUPPL	2020-09-11
64543	SUPPL	2020-09-10
54790	SUPPL	2018-07-06
54715	SUPPL	2018-06-28
54714	SUPPL	2018-06-28
54708	SUPPL	2018-06-27
54707	SUPPL	2018-06-27
41675	SUPPL	2016-07-27
20919	SUPPL	2016-07-27
20918	SUPPL	2016-07-27
41674	SUPPL	2013-02-27
25726	SUPPL	2011-01-25
13360	SUPPL	2011-01-25
3282	SUPPL	2010-06-02
35289	SUPPL	2010-05-28
41670	ORIG	2010-03-03
41672	SUPPL	2008-04-02
41673	SUPPL	2007-07-09
25725	SUPPL	2004-12-30
13359	SUPPL	2004-12-30
13356	SUPPL	2004-08-31
3280	SUPPL	2004-08-31
13358	SUPPL	2003-12-29
25724	SUPPL	2003-12-23
3281	SUPPL	2003-03-10
25723	SUPPL	2002-07-17
13357	SUPPL	2002-07-17
41671	SUPPL	1998-11-18
25722	SUPPL	1998-11-18
53343	ORIG	1900-01-01
53342	ORIG	1900-01-01
53341	ORIG	1900-01-01
53340	ORIG	1900-01-01
53339	ORIG	1900-01-01