terbinafine Oral Tablet

Brand(s)
Lamisil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-02-02)
Oldest Current Product
1996-05-10
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\TERBINAFINE
FDAOB
ORAL\TABLET\TERBINAFINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\TERBINAFINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\TERBINAFINE

product(s) by strength(s)

terbinafine 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780179LamisilNDANovartis Pharmaceuticals Corporation1996-05-10TERBINAFINE HYDROCHLORIDEORALTABLETNDA0205397c6c1494-fb92-4442-bcff-764b77397495

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1167140501ANDANorthstar Rx Llc2009-09-15TERBINAFINE HYDROCHLORIDEORALTABLETANDA078163742e7d17-36bf-4803-94c5-bc6be034be37
2317220209ANDACamber Pharmaceuticals, Inc.2011-01-01TERBINAFINE HYDROCHLORIDEORALTABLETANDA077533bcf7e761-786b-4ac8-aecd-ea1c745880b1
3519910526ANDABreckenridge Pharmaceutical, Inc.2010-12-27TERBINAFINE HYDROCHLORIDEORALTABLETANDA077714c3832113-f517-4b4e-bf9c-31fce1a638e1
4551110250ANDADr. Reddy'S Laboratories Ltd2007-07-02TERBINAFINE HYDROCHLORIDEORALTABLETANDA076390e0b309a5-bebe-c6da-2847-bda21aa488b1
5646790209ANDAWockhardt Usa Llc.2008-01-04TERBINAFINE HYDROCHLORIDEORALTABLETANDA077533f1950185-b677-42f6-a68e-d2b9e7c55e91
6658620079ANDAAurobindo Pharma Limited2007-07-02TERBINAFINE HYDROCHLORIDEORALTABLETANDA0782976600e2b3-65df-4fc3-8081-d574537d27e3
7674050500ANDAHarris Pharmaceutical, Inc.2014-08-13TERBINAFINE HYDROCHLORIDEORALTABLETANDA077137caf80893-b509-408e-8824-d911c5dc83e6
8674050543ANDAHarris Pharmaceutical, Inc.2007-07-30TERBINAFINE HYDROCHLORIDEORALTABLETANDA0779199912d2e8-e71e-4986-bb7c-3f2387be8e29
9762820209ANDAExelan Pharmaceuticals Inc.2012-04-25TERBINAFINE HYDROCHLORIDEORALTABLETANDA0775336dc279cc-9861-4fa8-8083-ca3b3c57b513

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1556480743ANDAWockhardt Limited2007-07-02TERBINAFINE HYDROCHLORIDEORALTABLETANDA07822960452f7e-f971-428b-aa6a-9e2c15480bf3
2646790743ANDAWockhardt Usa Llc.2007-07-02TERBINAFINE HYDROCHLORIDEORALTABLETANDA078229032f26c9-1218-4af0-9605-db3b34e5bd51

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950630ANDARebel Distributors Corp2007-07-02TERBINAFINE HYDROCHLORIDEORALTABLET658620079ANDA077533dfb8fc2d-4899-4891-a985-755fbdf1d525
2353560243ANDALake Erie Medical Dba Quality Care Products Llc2010-09-16TERBINAFINE HYDROCHLORIDEORALTABLET674050543ANDA07791908708dbf-d35c-48ed-9951-faefcba37ed0
3422910805ANDAAvkare, Inc.2011-10-20TERBINAFINE HYDROCHLORIDEORALTABLET674050543ANDA0779191e9e2bff-7a7e-e73d-c7b0-04fdb9bf0043
4430630598ANDAPd-Rx Pharmaceuticals, Inc.2014-08-13TERBINAFINE HYDROCHLORIDEORALTABLET674050500ANDA0771378ecadc65-087c-4de6-b1c0-e7df4727b610
5521250231ANDARemedyrepack Inc.2013-02-11TERBINAFINE HYDROCHLORIDEORALTABLET317220209ANDA07753341b59f4f-b7e0-44d4-9352-dd0b7008b521
6548685794ANDAPhysicians Total Care, Inc.2007-07-12TERBINAFINE HYDROCHLORIDEORALTABLET605052572ANDA078199393562a7-ef28-4186-9181-cadd09e9e089
7552890054ANDAPd-Rx Pharmaceuticals, Inc.2011-06-29TERBINAFINE HYDROCHLORIDEORALTABLET674050543ANDA077919aa9f660f-29e6-42fe-ba66-ee9387ce0385
8604290222ANDAGolden State Medical Supply, Inc.2010-12-27TERBINAFINE HYDROCHLORIDEORALTABLET519910526ANDA077714b43e4644-024c-4aa6-b403-19152c785802
9619190451ANDADirect Rx2015-01-01TERBINAFINE HYDROCHLORIDEORALTABLET674050500ANDA0771375fd8ccad-7187-4781-b0f8-60b83d2c3747
10631870213ANDAProficient Rx Lp2011-01-01TERBINAFINE HYDROCHLORIDEORALTABLET317220209ANDA07753387cac9b2-473a-449a-a678-11118097dc7f
11636292807ANDABryant Ranch Prepack2011-01-01TERBINAFINE HYDROCHLORIDEORALTABLET317220209ANDA077533d3592751-686b-48bd-a8d4-14c86bbcf510
12680840759ANDAAmerican Health Packaging2014-07-31TERBINAFINE HYDROCHLORIDEORALTABLET317220209ANDA077533ad65fe1c-1642-414d-a136-38ad627d63ed
13681511327ANDACarilion Materials Management2011-01-01TERBINAFINE HYDROCHLORIDEORALTABLET317220209ANDA077533984ad737-0cfe-4bee-888d-3a07b23cb7cd
14687889094ANDAPreferred Pharmaceuticals, Inc.2011-06-29TERBINAFINE HYDROCHLORIDEORALTABLET674050543ANDA0779195831d093-9a92-43c2-a384-1ba1537dbcf7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076377TERBINAFINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2007-07-02ANDA076377_001
2ANDA076390TERBINAFINE HYDROCHLORIDEDR REDDYS LABORATORIES INC2007-07-02ANDA076390_001
3ANDA077065TERBINAFINE HYDROCHLORIDETrueGEDEON RICHTER USA INC2007-07-02ANDA077065_001
4ANDA077136TERBINAFINE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INC2007-07-02ANDA077136_001
5ANDA077137TERBINAFINE HYDROCHLORIDECIPLA LTD2007-07-02ANDA077137_001
6ANDA077195TERBINAFINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2007-07-02ANDA077195_001
7ANDA077223TERBINAFINE HYDROCHLORIDETrueROXANE LABORATORIES INC2007-07-02ANDA077223_001
8ANDA077533TERBINAFINE HYDROCHLORIDEINVAGEN PHARMACEUTICALS INC2007-07-02ANDA077533_001
9ANDA077714TERBINAFINE HYDROCHLORIDEBRECKENRIDGE PHARMACEUTICAL INC2010-06-04ANDA077714_001
10ANDA077919TERBINAFINE HYDROCHLORIDEHARRIS PHARMACEUTICAL INC2007-07-02ANDA077919_001
11ANDA078157TERBINAFINE HYDROCHLORIDEGLENMARK GENERICS LTD2007-07-02ANDA078157_001
12ANDA078163TERBINAFINE HYDROCHLORIDEORCHID HEALTHCARE2007-07-02ANDA078163_001
13ANDA078199TERBINAFINE HYDROCHLORIDEAPOTEX CORP2007-07-02ANDA078199_001
14ANDA078229TERBINAFINE HYDROCHLORIDETrueWOCKHARDT LTD2007-07-02ANDA078229_001
15ANDA078297TERBINAFINE HYDROCHLORIDEAUROBINDO PHARMA LTD2007-07-02ANDA078297_001
16NDA020539LAMISILNOVARTIS PHARMACEUTICALS CORP1996-05-10NDA020539_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076377_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
2ANDA076390_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
3ANDA077065_001discontinuedTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalse2007-07-02TERBINAFINE HYDROCHLORIDE
4ANDA077136_001discontinuedTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalse2007-07-02TERBINAFINE HYDROCHLORIDE
5ANDA077137_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
6ANDA077195_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
7ANDA077223_001discontinuedTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalse2007-07-02TERBINAFINE HYDROCHLORIDE
8ANDA077533_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
9ANDA077714_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2010-06-04TERBINAFINE HYDROCHLORIDE
10ANDA077919_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
11ANDA078157_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
12ANDA078163_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
13ANDA078199_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
14ANDA078229_001discontinuedTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalse2007-07-02TERBINAFINE HYDROCHLORIDE
15ANDA078297_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETFalseAB2007-07-02TERBINAFINE HYDROCHLORIDE
16NDA020539_001RXTERBINAFINE HYDROCHLORIDE (EQ 250MG BASE)ORALTABLETTrueAB1996-05-10LAMISIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1032f26c9-1218-4af0-9605-db3b34e5bd51 (view SPL)Terbinafine Hydrochloride TabletsprescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-09-031646790743
208708dbf-d35c-48ed-9951-faefcba37ed0 (view SPL)Terbinafine Hydrochloride 250 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel2010-09-16389353560243
31e9e2bff-7a7e-e73d-c7b0-04fdb9bf0043 (view SPL)These highlights do not include all the information needed to use Terbinafine Hydrochloride Tablets safely and effectively. See full prescribing information for Terbinafine Hydrochloride.Terbinafine Hydrochloride (terbinafine hydrochloride) Tablet for oral use.Initial U.S. Approval 1992prescriptionHuman PrescriptionAvkare, Inc.MANUFACTURE2011-10-205422910805
4393562a7-ef28-4186-9181-cadd09e9e089 (view SPL)These highlights do not include all the information needed to use Terbinafine Tablets, USP safely and effectively. See full prescribing information for Terbinafine Tablets, USP. Terbinafine Hydrochloride Tablets, USP Initial U.S. Approval: 1992prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-071548685794
541b59f4f-b7e0-44d4-9352-dd0b7008b521 (view SPL)Terbinafine tablets, USP 250 mg for oral useThese highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride.Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use.Initial U.S. Approval: 1992prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-112521250231
65831d093-9a92-43c2-a384-1ba1537dbcf7 (view SPL)These highlights do not include all the information needed to use Terbinafine Hydrochloride Tablets safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (terbinafine hydrochloride) Tablet for oral use.Initial U.S. Approval: 1992prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.repack2011-08-021687889094
75fd8ccad-7187-4781-b0f8-60b83d2c3747 (view SPL)TERBINAFINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrepack2015-10-211619190451
860452f7e-f971-428b-aa6a-9e2c15480bf3 (view SPL)Terbinafine Hydrochloride TabletsprescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2012-09-071556480743
96600e2b3-65df-4fc3-8081-d574537d27e3 (view SPL)These highlights do not include all the information needed to use terbinafine tablets, USP safely and effectively. See full prescribing information for terbinafine tablets, USP. TERBINAFINE Tablets, USP 250 mg For oral useInitial U.S. Approval: 1992prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2013-11-0510658620079
106dc279cc-9861-4fa8-8083-ca3b3c57b513 (view SPL)These highlights do not include all the information needed to use terbinafine tablets safely and effectively. See full prescribing information for terbinafine tablets. Terbinafine tablets, USP 250 mg for oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionExelan Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2012-04-181762820209
11742e7d17-36bf-4803-94c5-bc6be034be37 (view SPL)These highlights do not include all the information needed to use terbinafine tablets, USP safely and effectively. See full prescribing information for terbinafine tablets, USP. Terbinafine Tablets USP, 250 mg For oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionNorthstar Rx Llc2013-11-1912167140501
127c6c1494-fb92-4442-bcff-764b77397495 (view SPL)These highlights do not include all the information needed to use LAMISIL Tablets safely and effectively. See full prescribing information for LAMISIL Tablets. LAMISIL (terbinafine hydrochloride) Tablets, 250 mg For oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-02-0214000780179
1387cac9b2-473a-449a-a678-11118097dc7f (view SPL)Terbinafine tablets, USP 250 mg for oral useThese highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use.Initial U.S. Approval: 1992prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-012631870213
148ecadc65-087c-4de6-b1c0-e7df4727b610 (view SPL)These highlights do not include all the information needed to use TERBINAFINE TABLETS, USP safely and effectively. See full prescribing information for TERBINAFINE TABLETS, USP. TERBINAFINE TABLETS, USP 250 mg For oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-08-222430630598
15984ad737-0cfe-4bee-888d-3a07b23cb7cd (view SPL)Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-09-182681511327
169912d2e8-e71e-4986-bb7c-3f2387be8e29 (view SPL)These highlights do not include all the information needed to use Terbinafine Tablets safely and effectively. See full prescribing information for Terbinafine Tablets. Terbinafine Tablets, USP, 250 mgFor oral use.Initial U.S. Approval: 1992prescriptionHuman PrescriptionHarris Pharmaceutical, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, REPACK2013-10-2415674050543
17aa9f660f-29e6-42fe-ba66-ee9387ce0385 (view SPL)These highlights do not include all the information needed to use Terbinafine Hydrochloride Tablets safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (terbinafine hydrochloride) Tablet for oral use.Initial U.S. Approval: 1992prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-08-113552890054
18ad65fe1c-1642-414d-a136-38ad627d63ed (view SPL)These highlights do not include all the information needed to use terbinafine tablets safely and effectively. See full prescribing information for terbinafine tablets.TERBINAFINE Tablets, USP 250 mg for oral useInitial U.S. Approval: 1992prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-09-121680840759
19b43e4644-024c-4aa6-b403-19152c785802 (view SPL)These highlights do not include all the information needed to use Terbinafine, USP 250MG safely and effectively. See full prescribing information for Terbinafine, USP 250MG.Initial U.S. Approval: 1992prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290222
20bcf7e761-786b-4ac8-aecd-ea1c745880b1 (view SPL)Terbinafine tablets, USP 250 mg for oral useThese highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use.Initial U.S. Approval: 1992prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.MANUFACTURE2015-02-156317220209
21c3832113-f517-4b4e-bf9c-31fce1a638e1 (view SPL)These highlights do not include all the information needed to use terbinafine tablets safely and effectively. See full prescribing information for terbinafine tablets. Terbinafine tablets USP, 250 mg For oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2014-07-075519910526
22caf80893-b509-408e-8824-d911c5dc83e6 (view SPL)These highlights do not include all the information needed to use TERBINAFINE TABLETS, USP safely and effectively. See full prescribing information for TERBINAFINE TABLETS, USP. TERBINAFINE TABLETS, USP 250 mg For oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionHarris Pharmaceutical, Inc.API MANUFACTURE, MANUFACTURE2014-08-221674050500
23d3592751-686b-48bd-a8d4-14c86bbcf510 (view SPL)Terbinafine Hydrochloride TabletsprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2011-08-123636292807
24dfb8fc2d-4899-4891-a985-755fbdf1d525 (view SPL)Terbinafine Hydrochloride TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-02-091216950630
25e0b309a5-bebe-c6da-2847-bda21aa488b1 (view SPL)These highlights do not include all the information needed to use terbinafine tablets safely and effectively. See full prescribing information for terbinafine tablets. Terbinafine Tablets USP, 250 mg For oral use Initial U.S. Approval: 1992prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2012-08-246551110250
26f1950185-b677-42f6-a68e-d2b9e7c55e91 (view SPL)Terbinafine Hydrochloride TabletsprescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, MANUFACTURE2009-11-251646790209

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII