Application 078541

Type: ANDA
Sponsor: GLENMARK GENERICS

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	Yes

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

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
A078541-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL			2008-05-28

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 · 42 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
2026-08-18 06:07:40	2026-07	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL			2008-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL			2008-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL			2008-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL			2008-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2008-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078541-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2008-05-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078541-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078541-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078541-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078541-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078541-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078541-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078541-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078541-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078541-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078541-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078541-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078541-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078541-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078541-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078541-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078541-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078541-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078541-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078541-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078541-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078541-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078541-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078541-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078541-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078541-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078541-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078541-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078541-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078541-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078541-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078541-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078541-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078541-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078541-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078541-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078541-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078541-001	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	Proficient Rx LP	47a60763-671e-413b-b962-f7f11ba2f4d7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078541 application number: ANDA078541 ndc (product): 63187-432
Mometasone Furoate	MOMETASONE FUROATE	Glenmark Pharmaceuticals Inc., USA	96eafc06-0354-49ca-a684-a77bb2afc8f5	2020-05-31	Warnings, Adverse reactions	Exact identifier ndc (product): 68462-385
Mometasone Furoate	MOMETASONE FUROATE	Glenmark Pharmaceuticals Inc., USA	031283ed-988b-4698-8a2e-00f3d41c0f71	2019-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078541 application number: ANDA078541 ndc (product): 68462-192

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-974	Mometasone Furoate	Mometasone Furoate	NORTHSTAR RX LLC	ANDA	Current
50090-2179	Mometasone Furoate	Mometasone Furoate	A-S Medication Solutions	ANDA	Current
53002-8320	Mometasone Furoate	Mometasone Furoate	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-432	Mometasone Furoate	Mometasone Furoate	Proficient Rx LP	ANDA	Current
63187-432	Mometasone Furoate	Mometasone Furoate	Proficient Rx LP	ANDA	Current
68071-1538	Mometasone Furoate	Mometasone Furoate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1538	Mometasone Furoate	Mometasone Furoate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1538	Mometasone Furoate	Mometasone Furoate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-192	Mometasone Furoate	Mometasone Furoate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-192	Mometasone Furoate	Mometasone Furoate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-192	Mometasone Furoate	Mometasone Furoate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-385	Mometasone Furoate	Mometasone Furoate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-385	Mometasone Furoate	Mometasone Furoate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-1992	Mometasone Furoate	Mometasone Furoate	REMEDYREPACK INC.	ANDA	Current
70518-1992	Mometasone Furoate	Mometasone Furoate	REMEDYREPACK INC.	ANDA	Current