Clemastine Oral Tablet

Brand(s)
Allerhist-1, Dayhist-1, Tavist
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2012-07-31)
Oldest Current Product
1992-04-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\CLEMASTINE
FDAOB
ORAL\TABLET\CLEMASTINE FUMARATE
SPL Active
ORAL\TABLET\CLEMASTINE FUMARATE
SPL Moiety
ORAL\TABLET\CLEMASTINE

product(s) by strength(s)

clemastine fumarate 1.34 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000671190TavistNDANovartis Consumer Health, Inc.2010-01-01CLEMASTINE FUMARATEORALTABLETNDA020925da09ea30-067f-45bc-9dc8-6fdd63db9ee1

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130282ANDAL. Perrigo Company1996-07-11CLEMASTINE FUMARATEORALTABLETANDA074512385b3e90-1f1c-40c5-9f0a-3948bf3f0d9c
2003630282ANDAWalgreens1996-05-31CLEMASTINE FUMARATEORALTABLETANDA0745125243fbe1-e45d-4673-86bf-6f8454d36f39
3007811358ANDASandoz Inc1993-10-31CLEMASTINE FUMARATEORALTABLETANDA0734580690d8e8-468f-4842-a092-970a315c4d79
4243850183Dayhist-1ANDAGood Neighbor Pharmacy1996-06-28CLEMASTINE FUMARATEORALTABLETANDA07451276bcabd8-5bce-4f14-9b8e-3aadabbbc7a4
5301420282Dayhist-1ANDAKroger1996-08-07CLEMASTINE FUMARATEORALTABLETANDA0745122888d734-2b33-4c5d-acc8-8f428bc6f66e
6368000282Dayhist-1ANDATop Care (Topco Associates Llc)1996-07-23CLEMASTINE FUMARATEORALTABLETANDA07451218892e40-e033-43c9-9645-b49b4b42cb75
7372050228Allerhist-1ANDACardinal Health1997-09-30CLEMASTINE FUMARATEORALTABLETANDA07451202201bdb-58b9-4662-a2c0-5ff3efa4a1fc
8378080282Dayhist-1ANDAH-E-B1995-08-30CLEMASTINE FUMARATEORALTABLETANDA0745128c94d63d-ed19-4161-b733-263de6554faa
9425070282Dayhist-1ANDAHy-Vee1996-06-21CLEMASTINE FUMARATEORALTABLETANDA074512d0daae1c-f6fb-4a23-9aa9-0f68b1aea3c7
10493480686ANDASunmark2003-07-03CLEMASTINE FUMARATEORALTABLETANDA074512539e2c02-b258-45ea-8694-58ce5165ea7c
11560620282Dayhist-1ANDAPublix Super Markets, Inc1996-11-20CLEMASTINE FUMARATEORALTABLETANDA0745121257b2e0-4ae6-4aab-b1f3-c93fd70116c6
12597790282ANDACvs1996-08-28CLEMASTINE FUMARATEORALTABLETANDA074512116c5d15-71ca-44d0-9457-b34cce02c64b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685913ANDAPhysicians Total Care, Inc.2008-06-27CLEMASTINE FUMARATEORALTABLET007811358ANDA0734589aa4a1f9-fb03-4698-a278-4bbb6698b009
2681512456ANDACarilion Materials Management1993-10-31CLEMASTINE FUMARATEORALTABLET007811358ANDA07345874f3a9fb-c35e-4720-9538-0a0afe0a773d

clemastine fumarate 2.68 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930308ANDATeva Pharmaceuticals Usa Inc1992-04-01CLEMASTINE FUMARATEORALTABLETANDA07328314aaadca-7d86-47e8-8483-6e05d456949d
2007811359ANDASandoz Inc1993-10-31CLEMASTINE FUMARATEORALTABLETANDA0734591c63f519-5bd5-4698-89f0-091d9f1688f6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1516550425ANDANorthwind Pharmaceuticals, Llc2014-04-28CLEMASTINE FUMARATEORALTABLET000930308ANDA073283be4f8613-e4da-45e1-a5c0-e9337ca5d245

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA073282CLEMASTINE FUMARATETrueANI PHARMACEUTICALS INC1992-01-31ANDA073282_001, ANDA073282_002Clemastine Extended Release Oral Tablet
2ANDA073283CLEMASTINE FUMARATETEVA PHARMACEUTICALS USA INC1992-01-31ANDA073283_001Clemastine Extended Release Oral Tablet
3ANDA073458CLEMASTINE FUMARATESANDOZ INC1993-10-31ANDA073458_001Clemastine Extended Release Oral Tablet
4ANDA073459CLEMASTINE FUMARATESANDOZ INC1993-10-31ANDA073459_001Clemastine Extended Release Oral Tablet
5ANDA074512CLEMASTINE FUMARATEPERRIGO CO1995-11-22ANDA074512_001Clemastine Extended Release Oral Tablet
6NDA017661TAVISTTrueNOVARTIS PHARMACEUTICALS CORPNDA017661_001, NDA017661_002, NDA017661_003Clemastine Extended Release Oral Tablet
7NDA020925TAVIST-1NOVARTIS PHARMACEUTICALS CORP1992-08-21NDA020925_001Clemastine Extended Release Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073282_001discontinuedCLEMASTINE FUMARATE (1.34MG)ORALTABLETFalse1992-01-31CLEMASTINE FUMARATE
2ANDA073282_002discontinuedCLEMASTINE FUMARATE (1.34MG)ORALTABLETFalse1992-12-03CLEMASTINE FUMARATE
3ANDA073283_001RXCLEMASTINE FUMARATE (2.68MG)ORALTABLETTrueAB1992-01-31CLEMASTINE FUMARATE
4ANDA073458_001OTCCLEMASTINE FUMARATE (1.34MG)ORALTABLETFalse1993-10-31CLEMASTINE FUMARATE
5ANDA073459_001RXCLEMASTINE FUMARATE (2.68MG)ORALTABLETFalseAB1993-10-31CLEMASTINE FUMARATE
6ANDA074512_001OTCCLEMASTINE FUMARATE (1.34MG)ORALTABLETFalse1995-11-22CLEMASTINE FUMARATE
7NDA017661_001discontinuedCLEMASTINE FUMARATE (2.68MG)ORALTABLETFalseTAVIST
8NDA017661_002discontinuedCLEMASTINE FUMARATE (1.34MG)ORALTABLETFalseTAVIST
9NDA017661_003discontinuedCLEMASTINE FUMARATE (1.34MG)ORALTABLETFalse1992-08-21TAVIST
10NDA020925_001OTCCLEMASTINE FUMARATE (1.34MG)ORALTABLETTrue1992-08-21TAVIST-1

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102201bdb-58b9-4662-a2c0-5ff3efa4a1fc (view SPL)Cardinal Health Allerhist Drug FactsotcHuman OTCCardinal Health2009-08-121372050228
20690d8e8-468f-4842-a092-970a315c4d79 (view SPL)Drug FactsotcHuman OTCSandoz Inc2012-04-0910007811358
3116c5d15-71ca-44d0-9457-b34cce02c64b (view SPL)CVS Pharmacy, Inc. Allergy Relief Drug FactsotcHuman OTCCvs2012-07-181597790282
41257b2e0-4ae6-4aab-b1f3-c93fd70116c6 (view SPL)Publix Super Markets, Inc. Dayhist Allergy Drug FactsotcHuman OTCPublix Super Markets, Inc2012-05-291560620282
514aaadca-7d86-47e8-8483-6e05d456949d (view SPL)CLEMASTINE FUMARATE TABLETS, USP0308prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-07-313000930308
618892e40-e033-43c9-9645-b49b4b42cb75 (view SPL)Topco Dayhist Allergy Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2009-08-121368000282
71c63f519-5bd5-4698-89f0-091d9f1688f6 (view SPL)Clemastine Fumarate Tablets, USPprescriptionHuman PrescriptionSandoz Inc2012-01-2110007811359
82888d734-2b33-4c5d-acc8-8f428bc6f66e (view SPL)Kroger Co. Dayhist Allergy Drug FactsotcHuman OTCKroger2009-08-121301420282
9385b3e90-1f1c-40c5-9f0a-3948bf3f0d9c (view SPL)Perrigo Dayhist Allergy Drug FactsotcHuman OTCL. Perrigo Company2012-05-291001130282
105243fbe1-e45d-4673-86bf-6f8454d36f39 (view SPL)Walgreen Co. Wal-Hist Drug FactsotcHuman OTCWalgreens2012-07-181003630282
11539e2c02-b258-45ea-8694-58ce5165ea7c (view SPL)McKesson 12 Hour Allergy Relief Drug FactsotcHuman OTCSunmark2009-08-121493480686
1274f3a9fb-c35e-4720-9538-0a0afe0a773d (view SPL)Drug FactsotcHuman OTCCarilion Materials ManagementREPACK2012-04-092681512456
1376bcabd8-5bce-4f14-9b8e-3aadabbbc7a4 (view SPL)Amerisource Bergen Dayhist Allergy Drug FactsotcHuman OTCGood Neighbor Pharmacy2012-03-142243850183
148c94d63d-ed19-4161-b733-263de6554faa (view SPL)HEB Dayhist Allergy Drug FactsotcHuman OTCH-E-B2011-12-151378080282
159aa4a1f9-fb03-4698-a278-4bbb6698b009 (view SPL)Drug FactsotcHuman OTCPhysicians Total Care, Inc.relabel2012-05-211548685913
16be4f8613-e4da-45e1-a5c0-e9337ca5d245 (view SPL)Clemastine FumarateprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-07-211516550425
17d0daae1c-f6fb-4a23-9aa9-0f68b1aea3c7 (view SPL)Hy-Vee, Inc. Dayhist Allergy Drug FactsotcHuman OTCHy-Vee2012-07-181425070282
18da09ea30-067f-45bc-9dc8-6fdd63db9ee1 (view SPL)Drug FactsotcHuman OTCNovartis Consumer Health, Inc.ANALYSIS, MANUFACTURE2011-09-012000671190

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