Application 077137

Type: ANDA
Sponsor: CIPLA

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 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
A077137-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077137-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077137-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077137-001	AB	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077137-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077137-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077137-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077137-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077137-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077137-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077137-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077137-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077137-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077137-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077137-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077137-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077137-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077137-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077137-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077137-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077137-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077137-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077137-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077137-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077137-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077137-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077137-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077137-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077137-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077137-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077137-001	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TERBINAFINE HYDROCHLORIDE	TERBINAFINE TABLETS 250 MG	NuCare Pharmaceuticals,Inc.	bf020c17-578f-74c4-e053-2995a90a9e7d	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077137 application number: ANDA077137 ndc (product): 68071-2381
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5d01fde5-e4cf-6670-e053-2991aa0a5b15	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077137 application number: ANDA077137 ndc (product): 68071-1640
TERBINAFINE HYDROCHLORIDE	TERBINAFINE TABLETS 250 MG	Cipla USA Inc.	daf41866-6f2b-4483-b575-456becd6e85f	2021-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077137 application number: ANDA077137 ndc (product): 69097-731

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-598	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-598	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-598	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-598	Terbinafine Hydrochloride	Terbinafine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
61919-451	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	DirectRX	ANDA	Current
61919-451	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	DirectRX	ANDA	Current
63187-792	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-792	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
63629-8137	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8137	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67405-500	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Harris Pharmaceutical, Inc.	ANDA	Current
67405-500	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Harris Pharmaceutical, Inc.	ANDA	Current
68071-1640	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1640	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1640	Terbinafine Hydrochloride	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2381	TERBINAFINE HYDROCHLORIDE	Terbinafine Tablets 250 mg	NuCare Pharmaceuticals,Inc.	ANDA	Current
69097-731	TERBINAFINE HYDROCHLORIDE	Terbinafine Tablets 250 mg	Cipla USA Inc.	ANDA	Current
70518-3085	TERBINAFINE HYDROCHLORIDE	Terbinafine Tablets 250 mg	REMEDYREPACK INC.	ANDA	Current
71335-0257	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0257	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0257	Terbinafine Hydrochloride	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9008	ORIG	2007-07-05