Application 078297

Type: ANDA
Sponsor: AUROBINDO PHARMA

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
A078297-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	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
A078297-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078297-001	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	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078297-001	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	RS	2007-07-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078297-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078297-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078297-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078297-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078297-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078297-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078297-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078297-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078297-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078297-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078297-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078297-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078297-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078297-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078297-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078297-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078297-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078297-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078297-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078297-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078297-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078297-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078297-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078297-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078297-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078297-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078297-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078297-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078297-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078297-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078297-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078297-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078297-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078297-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078297-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078297-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078297-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078297-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078297-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078297-001	AB	1	`e64feba35796…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbinafine	TERBINAFINE HYDROCHLORIDE	American Health Packaging	4ee1b667-0cf6-46e4-a740-4fc27904d577	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	REMEDYREPACK INC.	44c6f6e7-e0c0-450e-83ce-1ed4f3efddec	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 70518-2941
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	5de4c245-7086-453b-b90a-7a1242ec2c0b	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 50090-3575
Terbinafine	TERBINAFINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	747fdc13-7c3a-4672-b50c-31c51037bda2	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
Terbinafine	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	085e0809-6b7f-447e-976e-8276c29daad6	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 68788-7450
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	838c6140-19b6-4c2b-aed7-3065bd67af07	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297
TERBINAFINE	TERBINAFINE	direct rx	c7cf55e2-f637-e2d9-e053-2995a90a6270	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 72189-243
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	0a54cc4f-0789-46ce-875f-df759aa95d9c	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 71205-061
Terbinafine	TERBINAFINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	87af930f-493c-590e-e053-2a95a90a804a	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 68071-4873
Terbinafine	TERBINAFINE HYDROCHLORIDE	Bryant Ranch Prepack	294bc1af-50e3-4bff-8d48-321e673033ce	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 71335-1124
Terbinafine	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	79a39fb1-12b7-4b1e-9f28-102af34d0459	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 50090-3654
Terbinafine	TERBINAFINE HYDROCHLORIDE	Aurobindo Pharma Limited	6600e2b3-65df-4fc3-8081-d574537d27e3	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 65862-079
Terbinafine	TERBINAFINE HYDROCHLORIDE	NorthStar Rx LLC	8f87e3e1-4c9c-497a-af20-8ab52cfeef60	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 16714-795
Terbinafine	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	50657431-1cd9-42dd-9cfc-57db8713d267	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078297 application number: ANDA078297 ndc (product): 71205-492

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-795	Terbinafine	Terbinafine Hydrochloride	NorthStar Rx LLC	ANDA	Current
50090-3575	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3575	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3575	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3654	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3654	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3654	Terbinafine	Terbinafine Hydrochloride	A-S Medication Solutions	ANDA	Current
53002-0550	Terbinafine	Terbinafine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-344	Terbinafine	Terbinafine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-344	Terbinafine	Terbinafine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-079	Terbinafine	Terbinafine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
68071-2579	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4712	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4712	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4873	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4873	Terbinafine	Terbinafine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7450	Terbinafine	Terbinafine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2941	Terbinafine	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2941	Terbinafine	Terbinafine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-061	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-061	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-061	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-492	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-492	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-492	Terbinafine	Terbinafine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1124	Terbinafine	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1124	Terbinafine	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1124	Terbinafine	Terbinafine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-243	TERBINAFINE	TERBINAFINE	direct rx	ANDA	Current