Application 021958

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMISIL AT	TERBINAFINE	GEL;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021958-001	LAMISIL AT	TERBINAFINE	1%	GEL / TOPICAL		RLD, RS	2006-07-24

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 · 41 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	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021958-001	LAMISIL AT	1%	GEL / TOPICAL	RLD, RS	2006-07-24	`cb3db0bc1861…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toenail Fungus Treatment	TERBINAFINE	Shenzhen Wankelai E-commerce Co., Ltd.	4dc1d7f7-e4ae-c54b-e063-6394a90aa420	2026-03-24	Warnings	Name fallback generic name: TERBINAFINE
Terbinafine	TERBINAFINE	REMEDYREPACK INC.	cacf5fe4-8c24-47ed-9a2b-b70aa5d45ef2	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	21f1bf77-4338-4b75-b513-80a0d98a722a	2025-12-12	Warnings	Name fallback brand name: Lamisil AT
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	d3e75665-e2d4-47d9-baaa-93817b5fbf00	2025-12-12	Warnings	Name fallback brand name: Lamisil AT
Terbinafine	TERBINAFINE	Cipla USA Inc.	18b16aad-1877-4b07-b532-f0ef4843af91	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE
Terbinafine	TERBINAFINE	REMEDYREPACK INC.	79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a	2025-03-28	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE
TERBINAFINE	TERBINAFINE	direct rx	c7cf55e2-f637-e2d9-e053-2995a90a6270	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE
TERBINAFINE	TERBINAFINE	Chartwell RX, LLC	8ea693ec-e2f2-4661-b144-17651018e9fb	2024-11-07	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE
Terbinafine	TERBINAFINE	Exelan Pharmaceuticals Inc.	6dc279cc-9861-4fa8-8083-ca3b3c57b513	2020-10-29	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE
Terbinafine	TERBINAFINE	Proficient Rx LP	3925dc10-ad66-46a8-bfa5-1a4314be3521	2020-01-01	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
28926	SUPPL	2012-03-26
28925	SUPPL	2010-01-15
21886	ORIG	2008-07-08
16643	ORIG	2006-07-27
6545	ORIG	2006-07-27