Application 077511

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDECREAM;TOPICAL1%NoNo

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
A077511-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02

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 · 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 UTC2026-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02cb3db0bc1861…

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEScholl's Wellness Company LLC31f59302-eaee-211b-e063-6294a90a08b02026-04-03WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.92b31fc4-0f02-4857-b11f-49b9f942ee842026-02-20WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 51672-2080
Walgreens Athletes FootTERBINAFINE HYDROCHLORIDEWalgreen Companyd706c56f-0123-4a5a-8c85-240cbe6ef7a52025-11-26WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 0363-2080
CVSTERBINAFINE HYDROCHLORIDECVS Pharmacy17684ba2-3c2c-4259-84fa-3833f19e5a4d2025-11-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 59779-523
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0a9e890c-1eed-4fde-a484-852a4dd135c22025-10-17WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc6016e546-6c02-4af0-888c-c0899865c5f02025-09-30WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 68788-9814
CVS Pharmacy Athletes FootTERBINAFINE HYDROCHLORIDECVS Pharmacy98a4ed66-2813-49de-8cda-94c41cc3ca9f2025-09-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 59779-080
Athletes FootTERBINAFINE HYDROCHLORIDEPublix Super Markets Inc.58293d62-089d-49ab-b691-dfd705ac9a9c2025-09-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 56062-080
equate Athletes FootTERBINAFINE HYDROCHLORIDEWal-Mart Stores Ince799c808-7c0f-482d-99d2-35fc34dbb2ea2025-08-14WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 49035-080
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEAmerisourceBergen93ea9e7f-6914-4df2-8ca0-27c4538066232025-07-28WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 24385-524
Athletes FootTERBINAFINE HYDROCHLORIDERite Aid Corporationa7b0a70b-a117-48cf-a6bc-260be1dac1e72025-07-28WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 11822-0080
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC28a3ece3-78fb-4121-86a7-adc4a9d9540f2025-07-21WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Athletes FootTERBINAFINE HYDROCHLORIDEH E B28db9a27-4d23-48ef-b1f3-08b993948c112025-07-15WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 37808-080
Kroger AntifungalTERBINAFINE HYDROCHLORIDEKroger Company32e79416-5de4-4f06-9fff-f8c36a1ad5db2025-07-15WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 30142-080
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEWALGREEN COMPANY2ba1924b-9967-4adb-9061-d023ef44ab3e2025-07-10WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDECardinal Health, 110 dba LEADERa9412747-c7f9-4242-91ed-3695f372f6c92025-07-09WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 70000-0338
Silka AntifungalTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.a32cf699-e63e-4bd3-a5af-9e1ba447e02e2025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 50066-080
Silka Jock ItchTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.326d8586-042f-44f8-8530-e46b7b777bc32025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 50066-208
AntifungalTERBINAFINE HYDROCHLORIDEMeijer Distribution Inc9daf3136-74b6-4410-8256-cbc9dd700f612025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 41250-080
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.ca9cd2bd-4805-4469-b754-01a7487b71a62025-07-01WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 51672-2140

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 78 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-8100Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0067-8100Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0067-8114Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0067-8114Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0179-8715KAISER PERMANENTETerbinafine HydrochlorideKaiser Foundation HospitalsANDACurrent
0363-2080WalgreensTerbinafine HydrochlorideWalgreen CompanyANDACurrent
0363-2080WalgreensTerbinafine HydrochlorideWalgreen CompanyANDACurrent
0363-2083Terbinafine HydrochlorideTerbinafine HydrochlorideWalgreen CompanyANDACurrent
0536-1117Terbinafine HydrochlorideTerbinafine HydrochlorideRugby Laboratories, Inc.ANDACurrent
0536-1117Terbinafine HydrochlorideTerbinafine HydrochlorideRugby Laboratories, Inc.ANDACurrent
11673-080Athletes FootTerbinafine HydrochlorideTarget CorporationANDACurrent
11673-080Athletes FootTerbinafine HydrochlorideTarget CorporationANDACurrent
11822-0080Athletes FootTerbinafine HydrochlorideRite Aid CorporationANDACurrent
21130-080Athletes FootTerbinafine HydrochlorideSafeway Inc.ANDACurrent
24385-524Good Neighbor PharmacyTerbinafine HydrochlorideAmerisourceBergenANDACurrent
24385-524Good Neighbor PharmacyTerbinafine HydrochlorideAmerisourceBergenANDACurrent
30142-080KrogerTerbinafine HydrochlorideKroger CompanyANDACurrent
30142-080KrogerTerbinafine HydrochlorideKroger CompanyANDACurrent
36800-080Athletes FootTerbinafine HydrochlorideTopco Associates LLCANDACurrent
37012-080ShopkoTerbinafine HydrochlorideShopko Stores Operating Co., LLCANDACurrent
37205-941Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal HealthANDACurrent
37205-941Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal HealthANDACurrent
37808-080Athletes FootTerbinafine HydrochlorideH E BANDACurrent
41163-080athletes footTerbinafine HydrochlorideSupervalu IncANDACurrent
41190-083ShopRiteTerbinafine HydrochlorideWAKEFERN FOOD CORPORATIONANDACurrent
41250-080AntifungalTerbinafine HydrochlorideMeijer Distribution IncANDACurrent
41250-080AntifungalTerbinafine HydrochlorideMeijer Distribution IncANDACurrent
41250-080AntifungalTerbinafine HydrochlorideMeijer Distribution IncANDACurrent
41520-080Antifungal FootTerbinafine HydrochlorideAmerican Sales CompanyANDACurrent
41520-080Antifungal FootTerbinafine HydrochlorideAmerican Sales CompanyANDACurrent
49035-080equateTerbinafine HydrochlorideWal-Mart Stores IncANDACurrent
49348-790Athletes FootTerbinafine HydrochlorideMcKessonANDACurrent
49348-790Athletes FootTerbinafine HydrochlorideStrategic Sourcing Services LLCANDACurrent
50066-080SilkaTerbinafine HydrochlorideGenomma Lab USA, Inc.ANDACurrent
50066-080SilkaTerbinafine HydrochlorideGenomma Lab USA, Inc.ANDACurrent
50066-208SilkaTerbinafine HydrochlorideGenomma Lab USA, Inc.ANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5810Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5810Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50804-080GoodSenseTerbinafine HydrochlorideGeiss, Destin & Dunn, Inc.ANDACurrent
51143-080Live BetterTerbinafine HydrochlorideThe Great Atlantic & Pacific Tea CompanyANDACurrent
51672-2080Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2080Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2083Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2140Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51769-121SilkaTerbinafine HydrochlorideAll Natural DynamicsANDACurrent
56062-080Athletes FootTerbinafine HydrochloridePublix Super Markets Inc.ANDACurrent
59779-080CVS PharmacyTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-080CVS PharmacyTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-080CVS PharmacyTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-523CVSTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-523CVSTerbinafine HydrochlorideCVS PharmacyANDACurrent
61715-158Preferred PlusTerbinafine HydrochloridePreferred Plus (Kinray)ANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63868-364Athletes FootTerbinafine HydrochlorideChain Drug Marketing Association, Inc.ANDACurrent
68016-080Terbinafine HydrochlorideTerbinafine HydrochloridePharmacy Value Alliance LLCANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred PharmaceuticalsANDACurrent
70000-0338Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal Health, 110 dba LEADERANDACurrent
70000-0338Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal HealthANDACurrent
70518-0553Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0553Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0553Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0670Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0670Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1736Lamisil ATTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1736Lamisil ATTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
73467-121SilkaTerbinafine HydrochloridePCGI WholesaleANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43123ORIG2012-03-28