Application 022071

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMISIL	TERBINAFINE HYDROCHLORIDE	GRANULE;ORAL	EQ 125MG BASE/PACKET	Yes	No
002	LAMISIL	TERBINAFINE HYDROCHLORIDE	GRANULE;ORAL	EQ 187.5MG BASE/PACKET	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022071-001	LAMISIL	TERBINAFINE HYDROCHLORIDE	EQ 125MG BASE/PACKET	GRANULE / ORAL		RLD	2007-09-28
N022071-002	LAMISIL	TERBINAFINE HYDROCHLORIDE	EQ 187.5MG BASE/PACKET	GRANULE / ORAL		RLD	2007-09-28

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`74a2ff9319b5…`

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 3 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	0f59271d-997f-4dcc-aae3-900b53df1c95	2025-01-09	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Dr.Reddys Laboratories Limited	e0b309a5-bebe-c6da-2847-bda21aa488b1	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	Bionpharma Inc.	34221c17-0d8c-4b56-8af3-c74efab4599e	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	8f6d7b1a-5a01-4cc5-b5b7-c126ae889557	2024-10-14	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	0a54cc4f-0789-46ce-875f-df759aa95d9c	2024-09-01	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	17e976c6-ee44-42c5-987f-5360ee6d7c1e	2024-08-29	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5d01fde5-e4cf-6670-e053-2991aa0a5b15	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	87af930f-493c-590e-e053-2a95a90a804a	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	715cae3e-4e86-48b3-e053-2a95a90afdc2	2024-06-10	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	294bc1af-50e3-4bff-8d48-321e673033ce	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	79a39fb1-12b7-4b1e-9f28-102af34d0459	2024-05-23	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	Aurobindo Pharma Limited	6600e2b3-65df-4fc3-8081-d574537d27e3	2024-04-18	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	NorthStar Rx LLC	8f87e3e1-4c9c-497a-af20-8ab52cfeef60	2024-04-18	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	50657431-1cd9-42dd-9cfc-57db8713d267	2024-04-01	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	e2ecf7a5-1c84-4977-8a87-d1bfb9658668	2024-02-07	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	c3832113-f517-4b4e-bf9c-31fce1a638e1	2023-12-22	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	ef8370dc-8ca4-411d-87e1-dc6af3191330	2023-12-09	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	6605103b-fd71-4438-8496-f48973b98901	2023-10-31	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	4e515f99-7fc7-4692-9105-8e87c27d4e79	2022-08-01	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	76f7525d-2005-4da8-a795-50ede6236c68	2022-07-01	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58167	SUPPL	2019-04-01
56373	SUPPL	2018-11-08
46957	SUPPL	2017-01-24
46947	SUPPL	2017-01-24
45230	SUPPL	2016-08-23
38192	SUPPL	2013-10-25
6827	SUPPL	2013-10-25
29202	SUPPL	2013-06-18
38191	SUPPL	2013-06-17
6826	SUPPL	2012-04-25
16894	SUPPL	2012-04-23
6825	SUPPL	2011-11-08
16893	SUPPL	2011-04-01
6824	SUPPL	2011-03-31
6823	SUPPL	2010-12-07
38190	SUPPL	2010-12-04
21926	ORIG	2009-03-12
38189	ORIG	2007-10-04
6822	ORIG	2007-10-04
53414	ORIG	1900-01-01
53413	ORIG	1900-01-01
53412	ORIG	1900-01-01