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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022071-001	LAMISIL	EQ 125MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022071-002	LAMISIL	EQ 187.5MG BASE/PACKET	GRANULE / ORAL	RLD	2007-09-28	`3a93d1ddd44b…`

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 3 · 59 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
CVS Pharmacy Athletes Foot	TERBINAFINE HYDROCHLORIDE	CVS Pharmacy	98a4ed66-2813-49de-8cda-94c41cc3ca9f	2025-09-25	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Athletes Foot	TERBINAFINE HYDROCHLORIDE	Publix Super Markets Inc.	58293d62-089d-49ab-b691-dfd705ac9a9c	2025-09-25	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