Application 077223

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	TABLET;ORAL	EQ 250MG BASE	No	No

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

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
A077223-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL			2007-07-02

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077223-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2007-07-02	`f41ea6bd6efb…`

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 2 of 4 · 65 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.	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 brand name: Terbinafine Hydrochloride 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
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
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	838c6140-19b6-4c2b-aed7-3065bd67af07	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
LAMISIL AT TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	Voyant Beauty, Inc.	1fd313ad-a3d9-6c86-e063-6394a90a7ae4	2025-09-17	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	53235270-6ffb-44c8-aa55-debf59e1d964	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: terbinafine hydrochloride generic name: TERBINAFINE HYDROCHLORIDE
equate Athletes Foot	TERBINAFINE HYDROCHLORIDE	Wal-Mart Stores Inc	e799c808-7c0f-482d-99d2-35fc34dbb2ea	2025-08-14	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Good Neighbor Pharmacy	TERBINAFINE HYDROCHLORIDE	AmerisourceBergen	93ea9e7f-6914-4df2-8ca0-27c453806623	2025-07-28	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Athletes Foot	TERBINAFINE HYDROCHLORIDE	Rite Aid Corporation	a7b0a70b-a117-48cf-a6bc-260be1dac1e7	2025-07-28	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	28a3ece3-78fb-4121-86a7-adc4a9d9540f	2025-07-21	Warnings	Name fallback brand name: Terbinafine Hydrochloride generic name: TERBINAFINE HYDROCHLORIDE
Athletes Foot	TERBINAFINE HYDROCHLORIDE	H E B	28db9a27-4d23-48ef-b1f3-08b993948c11	2025-07-15	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Kroger Antifungal	TERBINAFINE HYDROCHLORIDE	Kroger Company	32e79416-5de4-4f06-9fff-f8c36a1ad5db	2025-07-15	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	WALGREEN COMPANY	2ba1924b-9967-4adb-9061-d023ef44ab3e	2025-07-10	Warnings	Name fallback brand name: Terbinafine Hydrochloride generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Cardinal Health, 110 dba LEADER	a9412747-c7f9-4242-91ed-3695f372f6c9	2025-07-09	Warnings	Name fallback brand name: Terbinafine Hydrochloride generic name: TERBINAFINE HYDROCHLORIDE
Silka Antifungal	TERBINAFINE HYDROCHLORIDE	Genomma Lab USA, Inc.	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	2025-07-02	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Silka Jock Itch	TERBINAFINE HYDROCHLORIDE	Genomma Lab USA, Inc.	326d8586-042f-44f8-8530-e46b7b777bc3	2025-07-02	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Antifungal	TERBINAFINE HYDROCHLORIDE	Meijer Distribution Inc	9daf3136-74b6-4410-8256-cbc9dd700f61	2025-07-02	Warnings	Name fallback generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ca9cd2bd-4805-4469-b754-01a7487b71a6	2025-07-01	Warnings	Name fallback brand name: Terbinafine Hydrochloride 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
9020	ORIG	2007-07-05