Application 076679

Type: ANDA
Sponsor: TARO

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 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
A076679-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2004-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076679-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`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	A076679-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076679-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076679-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076679-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076679-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076679-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076679-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076679-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076679-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076679-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076679-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076679-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076679-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076679-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076679-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076679-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076679-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076679-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076679-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076679-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076679-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076679-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076679-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076679-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076679-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076679-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076679-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076679-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076679-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076679-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076679-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076679-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076679-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076679-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076679-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076679-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076679-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076679-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076679-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076679-001	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 · 8 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	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	c953bd40-8a52-4812-837a-baaf1b17b3aa	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	88f5622d-64da-42b7-8aa9-62a5da5ebfbb	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	79e13e15-5bd3-48b1-877a-1cd92abbc7c5	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679 ndc (product): 63629-8682
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	2f79063c-f7da-4e71-b054-d24b86dd386a	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679 ndc (product): 63629-8681
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	a12fef6b-681e-4f80-8bcd-3f01733f1a67	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679 ndc (product): 45802-257
Mometasone Furoate	MOMETASONE FUROATE	Sun Pharmaceutical Industries, Inc.	ce61920d-65df-4423-925d-091e624ea32e	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679 ndc (product): 51672-1315
Mometasone Furoate	MOMETASONE FUROATE	Proficient Rx LP	2bf06b19-4ed7-41a3-b6fc-29713c41965c	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679 ndc (product): 63187-288

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-257	Mometasone Furoate	Mometasone Furoate	Perrigo New York Inc.	ANDA	Current
45802-257	Mometasone Furoate	Mometasone Furoate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-257	Mometasone Furoate	Mometasone Furoate	Perrigo New York Inc.	ANDA	Current
45802-257	Mometasone Furoate	Mometasone Furoate	Perrigo New York Inc.	ANDA	Current
51672-1315	Mometasone Furoate	Mometasone Furoate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1315	Mometasone Furoate	Mometasone Furoate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
53002-8321	Mometasone Furoate	Mometasone Furoate	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-288	Mometasone Furoate	Mometasone Furoate	Proficient Rx LP	ANDA	Current
63187-288	Mometasone Furoate	Mometasone Furoate	Proficient Rx LP	ANDA	Current
63629-8681	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8681	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8682	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
63629-8682	Mometasone Furoate	Mometasone Furoate	Bryant Ranch Prepack	ANDA	Current
68071-4249	Mometasone Furoate	Mometasone Furoate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2883	Mometasone Furoate	Mometasone Furoate	REMEDYREPACK INC.	ANDA	Current
70518-2883	Mometasone Furoate	Mometasone Furoate	REMEDYREPACK INC.	ANDA	Current
70518-2883	Mometasone Furoate	Mometasone Furoate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8947	ORIG	2004-12-30