Application 021124

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMISIL AT	TERBINAFINE HYDROCHLORIDE	SOLUTION;TOPICAL	1%	Yes	Yes
002	LAMISIL AT	TERBINAFINE HYDROCHLORIDE	SPRAY;TOPICAL	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021124-001	LAMISIL AT	TERBINAFINE HYDROCHLORIDE	1%	SOLUTION / TOPICAL		RLD, RS	2000-03-17
N021124-002	LAMISIL AT	TERBINAFINE HYDROCHLORIDE	1%	SPRAY / TOPICAL		RLD, RS	2000-03-17

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021124-001	LAMISIL AT	1%	SOLUTION / TOPICAL	RLD, RS	2000-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021124-002	LAMISIL AT	1%	SPRAY / TOPICAL	RLD, RS	2000-03-17	`782e0a99824c…`

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
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	21f1bf77-4338-4b75-b513-80a0d98a722a	2025-12-12	Warnings	Exact identifier application applno (NDA): 021124 application number: NDA021124
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	d3e75665-e2d4-47d9-baaa-93817b5fbf00	2025-12-12	Warnings	Exact identifier application applno (NDA): 021124 application number: NDA021124

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0067-6292	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6292	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6293	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer	NDA	Current
0067-6296	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6296	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6296	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6297	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6297	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6297	LAMISIL	TERBINAFINE HYDROCHLORIDE	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56098	SUPPL	2018-10-26
56068	SUPPL	2018-10-23
36163	SUPPL	2013-11-19
4389	SUPPL	2013-11-15
4388	SUPPL	2012-03-26
4387	SUPPL	2010-02-22
4386	SUPPL	2009-06-17
26833	SUPPL	2008-07-31
41965	ORIG	2002-05-15
14442	ORIG	2000-03-17
4385	ORIG	2000-03-17