Application 022518

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	AEROSOL, METERED;INHALATION	0.005MG/INH;0.1MG/INH	Yes	Yes
002	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	AEROSOL, METERED;INHALATION	0.005MG/INH;0.2MG/INH	Yes	Yes
003	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	AEROSOL, METERED;INHALATION	0.005MG/INH;0.05MG/INH	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N022518-001	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22
N022518-002	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22
N022518-003	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;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 4 of 4 · 131 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022518-001	7067502	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	7566705	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7067502	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7566705	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7067502	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7566705	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7067502	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7566705	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7067502	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7566705	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7067502	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7566705	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7067502	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7566705	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7067502	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7566705	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7067502	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7566705	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7067502	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7566705	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`b00525d2431f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 60 observed states.

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	N022518-003	NS	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022518-003	PED	2023-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022518-003	NS	2022-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022518-003	PED	2023-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022518-003	NS	2022-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022518-003	PED	2023-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022518-001	M-214	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	PED	2021-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	M-214	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	PED	2021-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022518-003	NS	2022-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022518-003	PED	2023-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022518-001	PED	2021-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022518-002	PED	2021-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022518-003	NS	2022-08-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022518-003	PED	2023-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-001	PED	2021-06-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-002	PED	2021-06-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-003	NS	2022-08-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-003	PED	2023-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022518-001	PED	2021-06-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022518-002	PED	2021-06-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022518-003	NS	2022-08-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022518-003	PED	2023-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022518-001	M-214	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	PED	2021-06-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	M-214	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	PED	2021-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022518-001	M-214	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	PED	2021-06-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	M-214	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	PED	2021-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022518-001	M-214	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	PED	2021-06-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	M-214	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	PED	2021-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022518-001	M-214	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	PED	2021-06-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	M-214	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	PED	2021-06-20	`b00525d2431f…`

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
Dulera	MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE	Organon LLC	8f399784-f257-4f31-b3dc-368bf2a1864d	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022518 application number: NDA022518 ndc (product): 78206-127 ndc (product): 78206-126 ndc (product): 78206-125

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-2223	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-2223	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-2223	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-2223	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-4610	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-4610	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-4610	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-4610	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-4610	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-4610	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-7206	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-7206	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-7206	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-7206	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-7206	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
0085-7206	Dulera	mometasone furoate and formoterol fumarate dihydrate	Merck Sharp & Dohme Corp.	NDA	Current
50090-1916	Dulera	mometasone furoate and formoterol fumarate dihydrate	A-S Medication Solutions	NDA	Current
78206-125	Dulera	mometasone furoate and formoterol fumarate dihydrate	Organon LLC	NDA	Current
78206-125	Dulera	mometasone furoate and formoterol fumarate dihydrate	Organon LLC	NDA	Current
78206-126	Dulera	mometasone furoate and formoterol fumarate dihydrate	Organon LLC	NDA	Current
78206-126	Dulera	mometasone furoate and formoterol fumarate dihydrate	Organon LLC	NDA	Current
78206-127	Dulera	mometasone furoate and formoterol fumarate dihydrate	Organon LLC	NDA	Current
78206-127	Dulera	mometasone furoate and formoterol fumarate dihydrate	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85777	SUPPL	2026-04-28
82642	SUPPL	2025-06-24
59685	SUPPL	2019-08-13
59684	SUPPL	2019-08-13
53514	SUPPL	2018-03-29
53513	SUPPL	2018-03-29
53468	SUPPL	2018-03-27
53467	SUPPL	2018-03-27
50927	SUPPL	2017-12-27
50837	SUPPL	2017-12-22
48867	SUPPL	2017-06-29
48848	SUPPL	2017-06-28
29821	SUPPL	2016-07-13
17673	SUPPL	2016-07-13
7494	SUPPL	2015-12-29
38805	SUPPL	2015-04-24
29820	SUPPL	2014-04-18
29819	SUPPL	2013-08-22
17672	SUPPL	2013-08-22
17671	SUPPL	2013-08-09
7493	SUPPL	2013-08-01
38804	SUPPL	2013-01-22
7492	SUPPL	2013-01-17
29818	SUPPL	2012-11-29
29817	SUPPL	2012-11-29
17670	SUPPL	2012-11-28
7491	SUPPL	2012-11-26
29816	SUPPL	2012-08-23
17669	SUPPL	2012-08-22
38803	SUPPL	2011-08-24
38802	SUPPL	2011-08-24
29815	SUPPL	2011-08-22
7490	SUPPL	2011-08-22
42546	ORIG	2011-05-25
24329	ORIG	2011-05-25
7489	ORIG	2010-06-29
38801	ORIG	2010-06-24
64021	ORIG	1900-01-01
54119	ORIG	1900-01-01
54118	ORIG	1900-01-01
54117	ORIG	1900-01-01
52903	ORIG	1900-01-01
51384	SUPPL	1900-01-01