Application 077714

Type
ANDA
Sponsor
BRECKENRIDGE PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077714-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2010-06-04

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2010-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2010-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2010-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-043f01610625f2…
2019-09-15 20:21 UTC2019-09A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077714-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2010-06-04cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077714-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077714-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077714-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077714-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077714-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077714-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077714-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077714-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077714-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077714-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077714-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077714-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077714-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077714-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077714-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077714-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077714-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077714-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077714-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077714-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077714-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077714-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077714-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077714-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077714-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077714-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077714-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077714-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077714-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077714-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077714-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077714-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077714-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077714-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077714-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077714-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077714-001AB1cb3db0bc1861…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENorthwind Health Company, LLCab6f50a5-87ce-0819-e053-2a95a90a22b72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 51655-364
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEGolden State Medical Supply, Inc.b43e4644-024c-4aa6-b403-19152c7858022025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 60429-222
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2df111dc-ecac-4161-9e22-38436eb37c1f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 43063-906
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack17e976c6-ee44-42c5-987f-5360ee6d7c1e2024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 71335-0918
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.715cae3e-4e86-48b3-e053-2a95a90afdc22024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 68071-4500
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepacke2ecf7a5-1c84-4977-8a87-d1bfb96586682024-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepackfacaea7f-cb4d-410f-85e4-e1ac9ff565ac2024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 63629-1993
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.c3832113-f517-4b4e-bf9c-31fce1a638e12023-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 51991-526
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEA-S Medication Solutions6605103b-fd71-4438-8496-f48973b989012023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 50090-1048
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEProficient Rx LP4e515f99-7fc7-4692-9105-8e87c27d4e792022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 71205-127
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC808dab18-43f1-4895-a023-edbde722863e2017-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077714
application number: ANDA077714
ndc (product): 43353-893

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-906Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-906Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-906Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-906Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-906Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-906Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-906Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-893Terbinafine HydrochlorideTerbinafine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-1048Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1048Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
51655-364Terbinafine HydrochlorideTerbinafine HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-364Terbinafine HydrochlorideTerbinafine HydrochlorideNorthwind PharmaceuticalsANDACurrent
51991-526Terbinafine HydrochlorideTerbinafine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-526Terbinafine HydrochlorideTerbinafine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-526Terbinafine HydrochlorideTerbinafine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-526Terbinafine HydrochlorideTerbinafine HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
60429-222Terbinafine HydrochlorideTerbinafine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-222Terbinafine HydrochlorideTerbinafine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-222Terbinafine HydrochlorideTerbinafine HydrochlorideGolden State Medical SupplyANDACurrent
60429-222Terbinafine HydrochlorideTerbinafine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63629-1993Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1993Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1993Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
68071-4500Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4500Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4500Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4578Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4578Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7187Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7187Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7187Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7187Terbinafine HydrochlorideTerbinafine HydrochloridePreferred PharmaceuticalsANDACurrent
68788-7187Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-1743Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1743Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1743Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1743Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-947Terbinafine HydrochlorideTerbinafine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-127Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
71205-127Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
71205-127Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
71205-127Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
71205-127Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
71335-0918Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0918Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0918Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent