Application 076788

Type: ANDA
Sponsor: TARO

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 43.

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
A076788-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL			2006-03-15

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 · 43 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
2026-09-14 22:38:34	2026-08	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2006-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2006-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2006-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2006-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076788-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2006-03-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A076788-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076788-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076788-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076788-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076788-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076788-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076788-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076788-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076788-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076788-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076788-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076788-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076788-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076788-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076788-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076788-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076788-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076788-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076788-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076788-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076788-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076788-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076788-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076788-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076788-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076788-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076788-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076788-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076788-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076788-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076788-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076788-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076788-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076788-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076788-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076788-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076788-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076788-001	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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	a12fef6b-681e-4f80-8bcd-3f01733f1a67	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Sun Pharmaceutical Industries, Inc.	ce61920d-65df-4423-925d-091e624ea32e	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
MOMETASONE FUROATE	MOMETASONE FUROATE	Aurohealth LLC	48ba8c52-73b6-4ee9-ba13-756a645a9183	2024-11-25	Warnings	Name fallback brand name: MOMETASONE FUROATE generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	43a91066-1d85-4f67-9856-a11c1bb2b22b	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	6c7d8133-b71e-4290-bec1-53ff0232998a	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Childrens Nasonex	MOMETASONE FUROATE	L. Perrigo Company	e15d055e-9a25-46b4-8724-3609cf2dc062	2024-08-28	Warnings	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	45c9512b-9463-4684-bfdb-742644d77cc3	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Proficient Rx LP	2bf06b19-4ed7-41a3-b6fc-29713c41965c	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Cosette Pharmaceuticals, Inc.	f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d92	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Cosette Pharmaceuticals, Inc.	f5b30e5e-b067-e28c-b7c5-aa58f4c57f09	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	c3053a64-9044-496e-9005-12b4440d46e8	2023-10-20	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	d15edb8b-c8b2-4023-992e-f79cefa2d1e8	2023-08-16	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	a6055a9c-e19c-48ad-a743-c0a7f7366cdd	2023-07-18	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	5f1f2136-9e10-4d43-bb35-ed285c744fe4	2023-07-18	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	7296b4a2-f180-4887-a8e0-029f81aec566	2023-04-21	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE FUROATE	A-S Medication Solutions	9fe65193-b4d8-480b-89b3-178cd1b20713	2023-02-15	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate generic name: MOMETASONE FUROATE
Sinuva	MOMETASONE FUROATE	Intersect ENT, Inc.	e33c1b23-cdc6-4f64-94ba-24b0b42c09bf	2023-01-26	Warnings, Adverse reactions	Name fallback generic name: MOMETASONE FUROATE
Mometasone Furoate	MOMETASONE	Amneal Pharmaceuticals LLC	ff41e901-5a6f-4ad5-be8a-a68eae787e5e	2022-08-20	Warnings, Adverse reactions	Name fallback brand name: Mometasone Furoate

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-1305	Mometasone Furoate	Mometasone Furoate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1305	Mometasone Furoate	Mometasone Furoate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current