Application 021385

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERTACZO	SERTACONAZOLE NITRATE	CREAM;TOPICAL	2%	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
N021385-001	ERTACZO	SERTACONAZOLE NITRATE	2%	CREAM / TOPICAL		RLD, RS	2003-12-10

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	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`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
Ertaczo	SERTACONAZOLE NITRATE	Coral Way Pharma, LLC	c6fa8dc4-2620-474e-a9b4-6657d9cbfa96	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021385 application number: NDA021385
Ertaczo	SERTACONAZOLE NITRATE	Lacer Pharma, LLC	27d51f01-3282-34ea-e063-6394a90a91ed	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021385 application number: NDA021385

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
0187-5115	Ertaczo	Sertaconazole Nitrate	Bausch Health US LLC	NDA	Current
0187-5115	Ertaczo	Sertaconazole Nitrate	Bausch Health US, LLC	NDA	Current
0187-5115	Ertaczo	Sertaconazole Nitrate	Bausch Health US LLC	NDA	Current
0187-5115	Ertaczo	Sertaconazole Nitrate	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5115	Ertaczo	Sertaconazole Nitrate	Bausch Health US, LLC	NDA	Current
0187-5115	Ertaczo	Sertaconazole Nitrate	Bausch Health Americas, Inc.	NDA	Current
21695-454	ERTACZO	ERTACZO	Rebel Distributors Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65652	SUPPL	2020-12-21
65616	SUPPL	2020-12-17
36803	SUPPL	2014-01-23
5233	SUPPL	2014-01-23
5232	SUPPL	2005-11-30
42132	ORIG	2004-03-08
27645	ORIG	2003-12-16
36802	ORIG	2003-12-10