Application 077678

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOMETASONE FUROATE	MOMETASONE FUROATE	LOTION;TOPICAL	0.1%	No	No

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
A077678-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL			2007-11-21

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2007-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077678-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2007-11-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077678-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077678-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077678-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077678-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077678-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077678-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077678-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077678-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077678-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077678-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077678-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077678-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077678-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077678-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077678-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077678-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077678-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077678-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077678-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077678-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077678-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077678-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077678-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077678-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077678-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077678-001	AB	1	`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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mometasone Furoate	MOMETASONE FUROATE	Preferred Pharmaceuticals Inc.	831f7694-8153-4a79-a453-48020b26f035	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Preferred Pharmaceuticals Inc.	bfe3d098-a5f8-4e5d-9fa6-eac167bad3e9	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
ASMANEX	MOMETASONE FUROATE	Organon LLC	10b36fb2-6b0d-4f20-b197-3564d6f594b9	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	0c6d63da-41bc-4894-bead-198e66c848ac	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	5eda1256-001a-4f40-b3ca-15349d532033	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Torrent Pharmaceuticals Limited	18ef90de-f74d-492f-a125-49da1875bd29	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone furoate	MOMETASONE FUROATE	Encube Ethicals, Inc.	dae3eaea-fc17-48a2-ae30-2a68f7811bce	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Mometasone furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Sportpharm LLC	f02dea3f-9e4f-4c5a-bea3-f428afca803b	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Preferred Pharmaceuticals Inc.	ad47cceb-e471-48d6-85d6-e4a3f10e2ac6	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	A-S Medication Solutions	16e134c7-39fb-4d16-9c24-a6df438967bf	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
ALLERGY RELIEF	MOMETASONE FUROATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	97681a68-c26a-4ec9-ac67-4480878fa43d	2026-01-05	Warnings	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	c953bd40-8a52-4812-837a-baaf1b17b3aa	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	88f5622d-64da-42b7-8aa9-62a5da5ebfbb	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
MOMETASONE FUROATE	MOMETASONE FUROATE	Encube Ethicals, Inc.	1ebaac16-432e-4e92-9d58-718bd76ae368	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: MOMETASONE FUROATE generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	79e13e15-5bd3-48b1-877a-1cd92abbc7c5	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	2f79063c-f7da-4e71-b054-d24b86dd386a	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Nasonex	MOMETASONE FUROATE	L. Perrigo Company	13696a8b-366a-4a5e-adea-d5b7bff9e46f	2025-08-19	Warnings	Name fallback generic name: MOMETASONE FUROATE
Leader Allergy Nasal	MOMETASONE FUROATE	Cardinal Health 110, LLC. dba Leader	26f929e8-0759-4584-a0bf-f7709baa6bee	2025-08-11	Warnings	Name fallback generic name: MOMETASONE FUROATE
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 brand name: MOMETASONE FUROATE generic name: MOMETASONE FUROATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0701	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0701	Mometasone Furoate	Mometasone Furoate	G&W Laboratories, Inc.	ANDA	Current
0713-0701	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0701	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
67405-275	Mometasone Furoate	Mometasone Furoate	Harris Pharmaceutical, Inc.	ANDA	Current