Application 205175

Type: NDA
Sponsor: GLENMARK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ECOZA	ECONAZOLE NITRATE	AEROSOL, FOAM;TOPICAL	1%	Yes	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
N205175-001	ECOZA	ECONAZOLE NITRATE	1%	AEROSOL, FOAM / TOPICAL		RLD, RS	2013-10-24

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205175-001	10071054	2031-08-08		Drug product	2018-09-27

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Econazole Nitrate	ECONAZOLE NITRATE	Trifluent Pharma, LLC	3eb40c94-f369-ce4b-e063-6294a90abed4	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205175 application number: NDA205175
Ecoza	ECONAZOLE NITRATE	Resilia Pharmaceuticals, Inc.	0bb5fa27-32ed-ed13-e063-6394a90a1577	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205175 application number: NDA205175

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23710-100	ECOZA	econazole nitrate	Exeltis USA Dermatology, LLC	NDA	Current
23710-100	ECOZA	econazole nitrate	Quinnova Pharmaceuticals, LLC	NDA	Current
23710-100	ECOZA	econazole nitrate	Exeltis USA Dermatology, LLC	NDA	Current
23710-100	ECOZA	econazole nitrate	Exeltis USA Dermatology, LLC	NDA	Current
72657-200	ECOZA	econazole nitrate	Glenmark Therapeutics Inc.,USA	NDA	Current
72657-200	ECOZA	econazole nitrate	Glenmark Therapeutics Inc.,USA	NDA	Current
72657-200	ECOZA	econazole nitrate	Glenmark Therapeutics Inc.,USA	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60975	SUPPL	2019-11-20
60971	SUPPL	2019-11-19
24488	ORIG	2014-06-27
22979	ORIG	2014-06-27
40455	ORIG	2013-10-25
10430	ORIG	2013-10-25
52445	ORIG	1900-01-01
52444	ORIG	1900-01-01
52440	ORIG	1900-01-01