Ethambutol Oral Tablet

Brand(s)
Myambutol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sti Pharma Llc (2015-05-07)
Oldest Current Product
2001-11-27
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\ETHAMBUTOL
FDAOB
ORAL\TABLET\ETHAMBUTOL HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\ETHAMBUTOL HYDROCHLORIDE
ORAL\TABLET\ETHAMBUTOL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\ETHAMBUTOL
ORAL\TABLET\ETHAMBUTOL

product(s) by strength(s)

ethambutol hydrochloride 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1688500010MyambutolNDASti Pharma Llc2007-08-10ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDNDA016320b362b3cd-2c26-4af5-baa4-084217729fa5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1548790001NDA AUTHORIZED GENERICSti Pharma2006-12-15ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDNDA0163203f6428d6-3745-4337-ad78-ebfff9f49135
2617480011ANDAVersapharm Incorporated2015-03-18ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA075095d7cf3a73-bfd3-438a-952d-71cf0ec61628
3681800280ANDALupin Pharmaceuticals, Inc.2009-07-04ETHAMBUTOL HYDROCHLORIDEORALTABLETANDA078939c732b415-e1f9-478f-896d-1dc8b6362da4
4688500004NDA AUTHORIZED GENERICSti Pharma Llc2006-12-15ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDNDA016320d123fbd1-57de-47c6-963f-54d69427290b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490065ANDARemedyrepack Inc.2010-11-11ETHAMBUTOL HYDROCHLORIDEORALTABLET688500010ANDA0750956ceeb4fb-6572-4f3d-84f6-bb2a7def32ef
2521250012ANDARemedyrepack Inc.2013-03-09ETHAMBUTOL HYDROCHLORIDEORALTABLET681800280ANDA078939c061de82-f2d1-4af0-ae08-066f5dade7d9
3681510149ANDACarilion Materials Management2009-07-04ETHAMBUTOL HYDROCHLORIDEORALTABLET681800280ANDA078939bb430cdb-ba6a-4b14-acb2-fbccdbf735d6

ethambutol hydrochloride 400 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1688500012MyambutolNDASti Pharma Llc2007-08-10ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDNDA016320b362b3cd-2c26-4af5-baa4-084217729fa5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550923ANDABarr Laboratories Inc.2001-11-27ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA076057b9487a8c-5b28-4592-a994-3e378635983f
2548790002NDA AUTHORIZED GENERICSti Pharma2006-12-15ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDNDA0163203f6428d6-3745-4337-ad78-ebfff9f49135
3617480014ANDAVersapharm Incorporated2015-03-18ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA075095d7cf3a73-bfd3-438a-952d-71cf0ec61628
4688500005NDA AUTHORIZED GENERICSti Pharma Llc2006-12-15ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATEDNDA016320d123fbd1-57de-47c6-963f-54d69427290b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490446ANDARemedyrepack Inc.2011-08-01ETHAMBUTOL HYDROCHLORIDEORALTABLET617480014ANDA07509529f40448-4f62-4557-9828-aaa39e92be28
2538080977NDAState Of Florida Doh Central Pharmacy2009-07-01ETHAMBUTOL HYDROCHLORIDEORALTABLET231550101NDA0163202f857930-d002-4abe-9907-bfd8fd7fe5ed
3545693070MyambutolNDAA-S Medication Solutions Llc2007-08-10ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATED688500012NDA016320e1937d75-7991-4803-803c-3cf74622faac
4548682876MyambutolNDAPhysicians Total Care, Inc.2007-08-10ETHAMBUTOL HYDROCHLORIDEORALTABLET688500012NDA0163203d523d8a-a5b8-44eb-8575-e36f186602a3
5548686219ANDAPhysicians Total Care, Inc.2010-12-20ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATED617480014ANDA075095b2f95b0b-9de3-4c0b-a46e-a7eee6428b4b
6551544550MyambutolNDACardinal Health2011-06-27ETHAMBUTOL HYDROCHLORIDEORALTABLET688500012NDA01632092e486cf-3a07-4178-b4df-52226e0401e1
7581180003ANDAClinical Solutions Wholesale2009-07-04ETHAMBUTOL HYDROCHLORIDEORALTABLET681800281ANDA0789399d6c2397-f0e4-42ff-8686-a77bf5513e4d
8617860359NDA AUTHORIZED GENERICRemedyrepack Inc.2015-06-29ETHAMBUTOL HYDROCHLORIDEORALTABLET, FILM COATED548790002NDA01632049c2acb4-a39a-4d4c-b817-5d1adf592a3a
9680840280ANDAAmerican Health Packaging2010-01-14ETHAMBUTOL HYDROCHLORIDEORALTABLET681800281ANDA078939d32e9865-8edd-4644-9939-62ed119db3ef

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075095ETHAMBUTOL HYDROCHLORIDEVERSAPHARM INC1999-11-30ANDA075095_001, ANDA075095_002
2ANDA076057ETHAMBUTOL HYDROCHLORIDEBARR LABORATORIES INC2001-11-26ANDA076057_001
3ANDA078939ETHAMBUTOL HYDROCHLORIDELUPIN LTD2009-06-17ANDA078939_001, ANDA078939_002
4NDA016320MYAMBUTOLSTI PHARMA LLCNDA016320_001, NDA016320_002, NDA016320_003, NDA016320_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075095_001RXETHAMBUTOL HYDROCHLORIDE (100MG)ORALTABLETFalseAB1999-11-30ETHAMBUTOL HYDROCHLORIDE
2ANDA075095_002RXETHAMBUTOL HYDROCHLORIDE (400MG)ORALTABLETFalseAB1999-11-30ETHAMBUTOL HYDROCHLORIDE
3ANDA076057_001RXETHAMBUTOL HYDROCHLORIDE (400MG)ORALTABLETFalseAB2001-11-26ETHAMBUTOL HYDROCHLORIDE
4ANDA078939_001RXETHAMBUTOL HYDROCHLORIDE (100MG)ORALTABLETFalseAB2009-06-17ETHAMBUTOL HYDROCHLORIDE
5ANDA078939_002RXETHAMBUTOL HYDROCHLORIDE (400MG)ORALTABLETFalseAB2009-06-17ETHAMBUTOL HYDROCHLORIDE
6NDA016320_001RXETHAMBUTOL HYDROCHLORIDE (100MG)ORALTABLETFalseABMYAMBUTOL
7NDA016320_002discontinuedETHAMBUTOL HYDROCHLORIDE (200MG)ORALTABLETFalseMYAMBUTOL
8NDA016320_003RXETHAMBUTOL HYDROCHLORIDE (400MG)ORALTABLETTrueABMYAMBUTOL
9NDA016320_004discontinuedETHAMBUTOL HYDROCHLORIDE (500MG)ORALTABLETFalseMYAMBUTOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
129f40448-4f62-4557-9828-aaa39e92be28 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-011493490446
22f857930-d002-4abe-9907-bfd8fd7fe5ed (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-251538080977
33d523d8a-a5b8-44eb-8575-e36f186602a3 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-051548682876
43f6428d6-3745-4337-ad78-ebfff9f49135 (view SPL)Ethambutol HydrochlorideTABLETS USP100 mg and 400 mgprescriptionHuman PrescriptionSti Pharma2012-08-161548790001, 548790002
549c2acb4-a39a-4d4c-b817-5d1adf592a3a (view SPL)Ethambutol HydrochlorideTABLETS USP100 mg and 400 mgprescriptionHuman PrescriptionRemedyrepack Inc.2015-06-291617860359
66ceeb4fb-6572-4f3d-84f6-bb2a7def32ef (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-05-1284493490065
792e486cf-3a07-4178-b4df-52226e0401e1 (view SPL)Myambutol Ethambutol Hydrochloride Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-12-082551544550
89d6c2397-f0e4-42ff-8686-a77bf5513e4d (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionClinical Solutions Wholesalerepack2015-08-052581180003
9b2f95b0b-9de3-4c0b-a46e-a7eee6428b4b (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-11-123548686219
10b362b3cd-2c26-4af5-baa4-084217729fa5 (view SPL)MyambutolprescriptionHuman PrescriptionSti Pharma Llc2015-05-073688500010, 688500012
11b9487a8c-5b28-4592-a994-3e378635983f (view SPL)ETHAMBUTOL HYDROCHLORIDETABLETS, USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-08-306005550923
12bb430cdb-ba6a-4b14-acb2-fbccdbf735d6 (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-04-132681510149
13c061de82-f2d1-4af0-ae08-066f5dade7d9 (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-093521250012
14c732b415-e1f9-478f-896d-1dc8b6362da4 (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2011-04-131681800280
15d123fbd1-57de-47c6-963f-54d69427290b (view SPL)Ethambutol HydrochlorideTABLETS USP100 mg and 400 mgprescriptionHuman PrescriptionSti Pharma Llcmanufacture2012-08-162688500004, 688500005
16d32e9865-8edd-4644-9939-62ed119db3ef (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-142680840280
17d7cf3a73-bfd3-438a-952d-71cf0ec61628 (view SPL)ETHAMBUTOL HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionVersapharm Incorporated2015-03-207617480011, 617480014
18e1937d75-7991-4803-803c-3cf74622faac (view SPL)Myambutol (Ethambutol Hydrochloride)TABLETS USP100 mg and 400 mgprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-261545693070

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