Application 215712

Type: NDA
Sponsor: PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NASONEX 24HR ALLERGY	MOMETASONE FUROATE	SPRAY, METERED;NASAL	0.05MG/SPRAY	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
N215712-001	NASONEX 24HR ALLERGY	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2022-03-17

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.

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	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`a50c72e98297…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare allergy	MOMETASONE FUROATE MONOHYDRATE	Topco Associates LLC	9e7c759e-d2cb-4505-ad9f-38efaaaeefc2	2026-06-11	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Allergy	MOMETASONE FUROATE MONOHYDRATE	Rite Aid Corporation	ec864592-bcee-4f45-97e8-34b28fe9e1a4	2026-06-03	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
allergy	MOMETASONE FUROATE MONOHYDRATE	HyVee Inc	9f83880b-0062-433a-bc4a-00886b975dd3	2026-03-29	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
allergy nasal	MOMETASONE FUROATE MONOHYDRATE	Walgreen Company	9f28b399-0035-4753-8d1b-ddea212f86e8	2026-03-06	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
basic care allergy	MOMETASONE FUROATE MONOHYDRATE	Amazon.com Services LLC	651bd156-bded-4bef-a951-dd35a6d5b97e	2026-02-03	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
ALLERGY RELIEF	MOMETASONE FUROATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	97681a68-c26a-4ec9-ac67-4480878fa43d	2026-01-05	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Nasonex	MOMETASONE FUROATE	L. Perrigo Company	13696a8b-366a-4a5e-adea-d5b7bff9e46f	2025-08-19	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712 ndc (product): 0113-1720
Leader Allergy Nasal	MOMETASONE FUROATE	Cardinal Health 110, LLC. dba Leader	26f929e8-0759-4584-a0bf-f7709baa6bee	2025-08-11	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Rugby mometasone furoate nasal	MOMETASONE FUROATE	Rugby Laboratories	b4c43535-ad22-44c2-b04f-df4348a6c485	2025-08-06	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
allergy	MOMETASONE FUROATE MONOHYDRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ca93cfef-56ac-49f9-9dac-36d19189f8a5	2025-03-11	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Childrens Nasonex	MOMETASONE FUROATE	L. Perrigo Company	e15d055e-9a25-46b4-8724-3609cf2dc062	2024-08-28	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-1720	Nasonex	mometasone furoate	L. Perrigo Company	NDA	Current
0113-1720	Nasonex	mometasone furoate	L. Perrigo Company	NDA	Current
0113-1720	Nasonex	mometasone furoate	L. Perrigo Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78755	SUPPL	2024-07-02
78756	SUPPL	2024-07-01
74372	SUPPL	2023-05-25
74371	SUPPL	2023-05-25
73729	SUPPL	2023-03-10
73726	SUPPL	2023-03-10
73348	SUPPL	2023-01-31
73308	SUPPL	2023-01-30
72135	SUPPL	2022-09-21
72134	SUPPL	2022-09-21
72131	SUPPL	2022-09-21
72122	SUPPL	2022-09-21
72121	SUPPL	2022-09-21
72107	SUPPL	2022-09-19
72049	ORIG	2022-09-09
71602	SUPPL	2022-07-19
71601	SUPPL	2022-07-19
71582	SUPPL	2022-07-18
71581	SUPPL	2022-07-18
70554	ORIG	2022-03-18
70553	ORIG	2022-03-18