Application 019599

Type: NDA
Sponsor: SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAFTIN	NAFTIFINE HYDROCHLORIDE	CREAM;TOPICAL	1%	Yes	No
002	NAFTIN	NAFTIFINE HYDROCHLORIDE	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019599-001	NAFTIN	NAFTIFINE HYDROCHLORIDE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29
N019599-002	NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019599-002	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 3 · 84 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2026-08-18 06:07:40	2026-07	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019599-001	NAFTIN	1%	CREAM / TOPICAL		RLD	1988-02-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019599-001	NAFTIN	1%	CREAM / TOPICAL		RLD	1988-02-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019599-001	NAFTIN	1%	CREAM / TOPICAL		RLD	1988-02-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`bb7c543d1eb4…`

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	N019599-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019599-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019599-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019599-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019599-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019599-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019599-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019599-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019599-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019599-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019599-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019599-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019599-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019599-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019599-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019599-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019599-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019599-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019599-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019599-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019599-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019599-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019599-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019599-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019599-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019599-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019599-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019599-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019599-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019599-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019599-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019599-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019599-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019599-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019599-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019599-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019599-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019599-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019599-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019599-002	AB	1	`e64feba35796…`

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	N019599-002	M-191	2019-11-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019599-002	M-191	2019-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019599-002	M-191	2019-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019599-002	M-191	2019-11-10	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92d3ec30-2176-49cd-8a70-668ef65e7663	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: NAFTIFINE HYDROCHLORIDE
Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	a740fc0d-45b3-411f-9dfd-f3d637b8a95f	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: NAFTIFINE HYDROCHLORIDE
Naftin	NAFTIFINE HYDROCHLORIDE	Sebela Pharmaceuticals Inc.	6645994a-ecb3-277b-e053-2a91aa0a81e5	2025-11-08	Warnings, Adverse reactions	Name fallback brand name: Naftin generic name: NAFTIFINE HYDROCHLORIDE
Naftin	NAFTIFINE HYDROCHLORIDE	Legacy Pharma USA Inc.	6c6ee055-4031-45a7-8561-ccd989343580	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Naftin generic name: NAFTIFINE HYDROCHLORIDE
Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d50961c2-e97f-4583-91d6-7cafd25a8c3d	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: NAFTIFINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0259-4126	Naftin	NAFTIFINE HYDROCHLORIDE	Merz Pharmaceuticals, LLC	NDA	Current
40085-201	Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Renaissance Pharma, Inc.	NDA	Current
40085-201	Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Renaissance Pharma, Inc.	NDA	Current
40085-203	Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Renaissance Pharma, Inc.	NDA	Current
40085-203	Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Renaissance Pharma, Inc.	NDA	Current
40085-203	Naftifine Hydrochloride	NAFTIFINE HYDROCHLORIDE	Renaissance Pharma, Inc.	NDA	Current
54766-102	Naftin	Naftifine Hydrochloride	Sebela Pharmaceuticals Inc.	NDA	Current
54766-102	Naftin	Naftifine Hydrochloride	Sebela Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62193	SUPPL	2020-03-19
53993	SUPPL	2018-05-03
53982	SUPPL	2018-05-02
45892	SUPPL	2016-11-15
45890	SUPPL	2016-11-14
40939	SUPPL	2015-11-05
11558	SUPPL	2014-10-15
17479	SUPPL	2014-10-14
11557	SUPPL	2012-01-23
17478	SUPPL	2012-01-18
1413	SUPPL	2009-01-30
51407	SUPPL	1900-01-01
51406	SUPPL	1900-01-01
51404	SUPPL	1900-01-01