Application 077447

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	CREAM;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
A077447-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077447-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077447-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077447-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077447-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077447-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077447-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077447-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077447-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077447-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077447-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077447-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077447-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077447-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077447-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077447-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077447-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077447-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077447-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077447-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077447-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077447-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077447-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077447-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077447-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077447-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077447-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077447-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077447-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077447-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077447-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077447-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077447-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077447-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077447-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077447-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077447-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077447-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077447-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077447-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077447-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077447-001	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 1 · 3 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.	ad47cceb-e471-48d6-85d6-e4a3f10e2ac6	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077447 application number: ANDA077447
Mometasone Furoate	MOMETASONE FUROATE	A-S Medication Solutions	16e134c7-39fb-4d16-9c24-a6df438967bf	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077447 application number: ANDA077447 ndc (product): 50090-2991
Mometasone Furoate	MOMETASONE FUROATE	Cosette Pharmaceuticals, Inc.	f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d92	2023-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077447 application number: ANDA077447 ndc (product): 0713-0634

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0634	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0634	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0634	Mometasone Furoate	Mometasone Furoate	G&W Laboratories, Inc.	ANDA	Current
0713-0634	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0634	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0726	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0726	Mometasone Furoate	Mometasone Furoate	Almus	ANDA	Current
0713-0726	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0726	Mometasone Furoate	Mometasone Furoate	Cosette Pharmaceuticals, Inc.	ANDA	Current
21695-786	Mometasone Furoate	Mometasone Furoate	Rebel Distributors Corp	ANDA	Current
50090-2991	Mometasone Furoate	Mometasone Furoate	A-S Medication Solutions	ANDA	Current
67405-100	Mometasone Furoate	Mometasone Furoate	Harris Pharmaceutical, Inc.	ANDA	Current
68071-4637	Mometasone Furoate	Mometasone Furoate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4637	Mometasone Furoate	Mometasone Furoate	NuCare Pharmaceuticals,Inc.	ANDA	Current