Application 077180

Type: ANDA
Sponsor: PERRIGO ISRAEL

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 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
A077180-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077180-001	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 · 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	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077180-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077180-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077180-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077180-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077180-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077180-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077180-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077180-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077180-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077180-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077180-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077180-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077180-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077180-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077180-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077180-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077180-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077180-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077180-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077180-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077180-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077180-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077180-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077180-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077180-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077180-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077180-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077180-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077180-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077180-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077180-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077180-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077180-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077180-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077180-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077180-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077180-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077180-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077180-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077180-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	6c7d8133-b71e-4290-bec1-53ff0232998a	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180 ndc (product): 63629-8686
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	d15edb8b-c8b2-4023-992e-f79cefa2d1e8	2023-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	5f1f2136-9e10-4d43-bb35-ed285c744fe4	2023-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180 ndc (product): 63629-8685
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	7296b4a2-f180-4887-a8e0-029f81aec566	2023-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180 ndc (product): 45802-118

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-118	Mometasone Furoate	Mometasone Furoate	Perrigo New York Inc	ANDA	Current
45802-118	Mometasone Furoate	Mometasone Furoate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-118	Mometasone Furoate	Mometasone Furoate	Perrigo New York Inc	ANDA	Current
63629-8685	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8685	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8685	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8686	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8686	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8686	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current