Application 204427

Type: NDA
Sponsor: ANACOR PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KERYDIN	TAVABOROLE	SOLUTION;TOPICAL	5%	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
N204427-001	KERYDIN	TAVABOROLE	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07

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2026-08-18 06:07:40	2026-07	N204427-001	KERYDIN	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204427-001	KERYDIN	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204427-001	KERYDIN	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204427-001	KERYDIN	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204427-001	KERYDIN	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204427-001	KERYDIN	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204427-001	KERYDIN	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD	2014-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD, RS	2014-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD, RS	2014-07-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD, RS	2014-07-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD, RS	2014-07-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL		RLD, RS	2014-07-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204427-001	KERYDIN	5%	SOLUTION / TOPICAL	AB	RLD, RS	2014-07-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204427-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204427-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204427-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204427-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204427-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204427-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204427-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204427-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204427-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204427-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204427-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204427-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204427-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204427-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204427-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204427-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204427-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204427-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204427-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204427-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204427-001	9549938	2026-02-16	U-1951		2017-02-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	9566289	2026-02-16		Drug product	2017-02-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	9566290	2026-02-16	U-1970		2017-02-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	9572823	2026-02-16	U-1970		2017-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	9549938*PED	2026-08-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	9566289*PED	2026-08-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	9566290*PED	2026-08-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	9572823*PED	2026-08-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	7582621	2027-05-26	U-2016	Delist requested	2014-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	7582621*PED	2027-11-26		Pediatric extension		`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9549938	2026-02-16	U-1951	Delist requested	2017-02-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9566289	2026-02-16		Drug product, Delist requested	2017-02-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9566290	2026-02-16	U-1970	Delist requested	2017-02-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9572823	2026-02-16	U-1970	Delist requested	2017-03-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9549938*PED	2026-08-16		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9566289*PED	2026-08-16		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9566290*PED	2026-08-16		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	9572823*PED	2026-08-16		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	7582621	2027-05-26	U-2016	Delist requested	2014-07-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204427-001	7582621*PED	2027-11-26		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9549938	2026-02-16	U-1951		2017-02-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9566289	2026-02-16		Drug product	2017-02-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9566290	2026-02-16	U-1970		2017-02-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9572823	2026-02-16	U-1970		2017-03-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9549938*PED	2026-08-16		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9566289*PED	2026-08-16		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9566290*PED	2026-08-16		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	9572823*PED	2026-08-16		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	7582621	2027-05-26	U-2016	Delist requested	2014-07-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204427-001	7582621*PED	2027-11-26		Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9549938	2026-02-16	U-1951		2017-02-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9566289	2026-02-16		Drug product	2017-02-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9566290	2026-02-16	U-1970		2017-02-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9572823	2026-02-16	U-1970		2017-03-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9549938*PED	2026-08-16		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9566289*PED	2026-08-16		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9566290*PED	2026-08-16		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	9572823*PED	2026-08-16		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	7582621	2027-05-26	U-2016	Delist requested	2014-07-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204427-001	7582621*PED	2027-11-26		Pediatric extension		`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204427-001	NCE	2019-07-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204427-001	PED	2020-01-07	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204427-001	PED	2020-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204427-001	PED	2020-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204427-001	NCE	2019-07-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204427-001	PED	2020-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204427-001	NCE	2019-07-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204427-001	PED	2020-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204427-001	NCE	2019-07-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204427-001	PED	2020-01-07	`ea99ee380514…`

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
TAVABOROLE	TAVABOROLE	Cipla USA Inc.	37004451-0345-4e00-96be-f05db600fb9f	2025-12-19	Adverse reactions	Name fallback generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Alembic Pharmaceuticals Limited	6da415c6-a9be-42bf-829f-e72ccc5fe3ba	2025-02-18	Adverse reactions	Name fallback generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Viona Pharmaceuticals Inc	c13610c8-c57a-4519-b37d-eb4fbdcec398	2024-12-06	Adverse reactions	Name fallback generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Zydus Lifesciences Limited	15bc62dc-4f5e-4d43-a125-d1f00bee84a5	2024-12-06		Name fallback generic name: TAVABOROLE
tavaborole	TAVABOROLE	Mayne Pharma Commercial LLC	7ad9dc39-7501-4db5-a935-d9be8eea30a6	2024-03-05	Adverse reactions	Name fallback generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Alembic Pharmaceuticals Inc.	22a6617b-d4b1-405e-901a-0b39a7b2837d	2023-12-15	Adverse reactions	Name fallback generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Chartwell RX, LLC	7fe75d38-80a0-444e-84bc-4087b45a791e	2023-09-15	Adverse reactions	Name fallback generic name: TAVABOROLE
Tavaborole	TAVABOROLE	Amneal Pharmaceuticals NY LLC	c7f19812-3811-4a3a-9909-43a7a7f134d4	2019-06-15	Adverse reactions	Name fallback generic name: TAVABOROLE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10337-905	Kerydin	Tavaborole	PharmaDerm, A division of Fougera Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55087	SUPPL	2018-08-03
55063	SUPPL	2018-07-31
40391	SUPPL	2015-03-04
10343	SUPPL	2015-03-02
44901	ORIG	2014-08-05
43464	ORIG	2014-08-05
32559	ORIG	2014-07-09
19560	ORIG	2014-07-08
64126	ORIG	1900-01-01
64125	ORIG	1900-01-01
63245	SUPPL	1900-01-01