Application 020539

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMISIL	TERBINAFINE HYDROCHLORIDE	TABLET;ORAL	EQ 250MG BASE	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
N020539-001	LAMISIL	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10

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	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL		RLD	1996-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL		RLD	1996-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1996-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020539-001	LAMISIL	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	1996-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020539-001	LAMISIL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-05-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020539-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020539-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020539-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020539-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020539-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020539-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020539-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020539-001	AB	1	`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 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	REMEDYREPACK INC.	2886b2ff-815f-4621-bc28-1fea082c1920	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Athlete Foot Cream	TERBINAFINE HYDROCHLORIDE	Beautivity LLC	3b2c1d7f-32c3-aa3b-e063-6394a90a6267	2026-06-29	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Scholl's Wellness Company LLC	31f59302-eaee-211b-e063-6294a90a08b0	2026-04-03	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	American Health Packaging	4ee1b667-0cf6-46e4-a740-4fc27904d577	2026-03-06	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92b31fc4-0f02-4857-b11f-49b9f942ee84	2026-02-20	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	REMEDYREPACK INC.	44c6f6e7-e0c0-450e-83ce-1ed4f3efddec	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Northwind Health Company, LLC	ab6f50a5-87ce-0819-e053-2a95a90a22b7	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	5de4c245-7086-453b-b90a-7a1242ec2c0b	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	21f1bf77-4338-4b75-b513-80a0d98a722a	2025-12-12	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	d3e75665-e2d4-47d9-baaa-93817b5fbf00	2025-12-12	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Walgreens Athletes Foot	TERBINAFINE HYDROCHLORIDE	Walgreen Company	d706c56f-0123-4a5a-8c85-240cbe6ef7a5	2025-11-26	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
CVS	TERBINAFINE HYDROCHLORIDE	CVS Pharmacy	17684ba2-3c2c-4259-84fa-3833f19e5a4d	2025-11-25	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	b43e4644-024c-4aa6-b403-19152c785802	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Voyant Beauty Inc.	9dea4789-bf1c-1577-e053-2a95a90a5381	2025-11-18	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Good Neighbor Pharmacy	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0a9e890c-1eed-4fde-a484-852a4dd135c2	2025-10-17	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2df111dc-ecac-4161-9e22-38436eb37c1f	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	747fdc13-7c3a-4672-b50c-31c51037bda2	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	1aa5e03a-432b-4154-ab6e-6dbce7a67109	2025-10-02	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc	6016e546-6c02-4af0-888c-c0899865c5f0	2025-09-30	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	085e0809-6b7f-447e-976e-8276c29daad6	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE

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
0078-0179	Lamisil	terbinafine hydrochloride	Novartis Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58212	SUPPL	2019-04-04
58174	SUPPL	2019-04-02
58168	SUPPL	2019-04-01
46956	SUPPL	2017-01-24
46949	SUPPL	2017-01-24
45402	SUPPL	2016-09-28
45232	SUPPL	2016-08-23
25138	SUPPL	2013-10-25
12697	SUPPL	2013-10-25
2692	SUPPL	2013-06-18
34801	SUPPL	2013-06-17
34800	SUPPL	2012-05-02
2691	SUPPL	2012-04-27
34799	SUPPL	2012-03-22
25137	SUPPL	2011-11-08
34798	SUPPL	2011-04-01
2690	SUPPL	2011-03-31
2689	SUPPL	2010-12-06
34797	SUPPL	2010-12-04
34796	SUPPL	2004-02-03
2688	SUPPL	2004-02-02
25135	ORIG	2001-05-03
25136	SUPPL	2001-04-13