Application 205641

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ASMANEX HFA	MOMETASONE FUROATE	AEROSOL, METERED;INHALATION	0.10MG/INH	Yes	No
002	ASMANEX HFA	MOMETASONE FUROATE	AEROSOL, METERED;INHALATION	0.20MG/INH	Yes	Yes
003	ASMANEX HFA	MOMETASONE FUROATE	AEROSOL, METERED;INHALATION	0.05MG/INH	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N205641-001	ASMANEX HFA	MOMETASONE FUROATE	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25
N205641-002	ASMANEX HFA	MOMETASONE FUROATE	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25
N205641-003	ASMANEX HFA	MOMETASONE FUROATE	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12

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 4 · 125 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205641-003	NS	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205641-003	PED	2023-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205641-003	NS	2022-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205641-003	PED	2023-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205641-003	NS	2022-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205641-003	PED	2023-02-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N205641-003	NS	2022-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205641-003	PED	2023-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205641-003	NS	2022-08-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205641-003	PED	2023-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205641-003	NS	2022-08-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205641-003	PED	2023-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205641-003	NS	2022-08-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205641-003	PED	2023-02-12	`5aa47cf7b7d7…`
2023-12-20 04:57 UTC	2023-12	N205641-003	PED	2023-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205641-003	PED	2023-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205641-003	PED	2023-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205641-003	PED	2023-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205641-003	PED	2023-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205641-003	PED	2023-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205641-003	NS	2022-08-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205641-003	PED	2023-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205641-003	NS	2022-08-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205641-003	PED	2023-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205641-003	NS	2022-08-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205641-003	PED	2023-02-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205641-003	NS	2022-08-12	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N205641-003	PED	2023-02-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205641-003	NS	2022-08-12	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205641-003	PED	2023-02-12	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	0c6d63da-41bc-4894-bead-198e66c848ac	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205641 application number: NDA205641 ndc (product): 78206-113 ndc (product): 78206-112 ndc (product): 78206-111

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-2222	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-2222	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-2222	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-2222	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4333	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4333	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4333	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4333	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4333	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4333	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4334	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4334	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4334	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4334	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4334	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
0085-4334	ASMANEX HFA	MOMETASONE FUROATE	Merck Sharp & Dohme Corp.	NDA	Current
78206-111	ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	NDA	Current
78206-111	ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	NDA	Current
78206-112	ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	NDA	Current
78206-112	ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	NDA	Current
78206-113	ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	NDA	Current
78206-113	ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59693	SUPPL	2019-08-13
59686	SUPPL	2019-08-13
53516	SUPPL	2018-03-29
53515	SUPPL	2018-03-29
53461	SUPPL	2018-03-27
53460	SUPPL	2018-03-27
40490	SUPPL	2016-07-13
10485	SUPPL	2016-07-13
40489	SUPPL	2015-08-04
40488	SUPPL	2015-07-10
32698	SUPPL	2015-06-18
44929	ORIG	2014-11-03
43497	ORIG	2014-11-03
19671	ORIG	2014-05-12
10484	ORIG	2014-05-01
63178	ORIG	1900-01-01
51383	SUPPL	1900-01-01
51382	ORIG	1900-01-01
51381	ORIG	1900-01-01
51380	ORIG	1900-01-01