trimethobenzamide Injectable Solution

Brand(s)
Tigan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2015-10-07)
Oldest Current Product
2007-11-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\TRIMETHOBENZAMIDE
FDAOB
INJECTION\INJECTION\TRIMETHOBENZAMIDE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\TRIMETHOBENZAMIDE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\TRIMETHOBENZAMIDE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\TRIMETHOBENZAMIDE
INTRAMUSCULAR\INJECTION\TRIMETHOBENZAMIDE

product(s) by strength(s)

trimethobenzamide hydrochloride 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230119TiganNDAPar Pharmaceutical Inc.2007-11-01TRIMETHOBENZAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA0175307da90678-b229-4ad6-9193-2b8a3e9ba695

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1420230142NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-012015-02-28TRIMETHOBENZAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA0175300797d0b2-a61d-4db8-a2ce-ce973a2eb064
2420230143NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-012016-12-31TRIMETHOBENZAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA0175300797d0b2-a61d-4db8-a2ce-ce973a2eb064

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840952ANDAGeneral Injecatables & Vaccines, Inc2010-03-01TRIMETHOBENZAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091952ANDA08880430a73005-ac90-467c-bedd-59d528e7930e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950853TiganNDARebel Distributors Corp2007-11-01TRIMETHOBENZAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION420230118NDA01753097191d37-7c2e-48c6-91bf-0631fd7b1dd8
2521250805NDA AUTHORIZED GENERICRemedyrepack Inc.2014-01-09TRIMETHOBENZAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION420230143NDA017530c1d3cc1f-f990-42b1-bc42-3551c1bfa12a
3525840119TiganNDAGeneral Injecatables & Vaccines, Inc2010-08-01TRIMETHOBENZAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION420230119NDA017530d86e48ca-7e98-4e9c-9b1e-f80fef1c7c2a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA086577TRIMETHOBENZAMIDE HYDROCHLORIDETrueWATSON LABORATORIES INC1982-10-19ANDA086577_001
2ANDA087939TRIMETHOBENZAMIDE HYDROCHLORIDETrueWATSON LABORATORIES INC1982-12-28ANDA087939_001
3ANDA088804TRIMETHOBENZAMIDE HYDROCHLORIDETrueHOSPIRA INC1987-04-03ANDA088804_001
4ANDA088960TRIMETHOBENZAMIDE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1986-04-04ANDA088960_001
5ANDA089043TRIMETHOBENZAMIDE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1986-04-04ANDA089043_001
6ANDA089094TRIMETHOBENZAMIDE HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INC1986-04-04ANDA089094_001
7ANDA091329TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREELUITPOLD PHARMACEUTICALS INC2011-03-08ANDA091329_001
8ANDA091330TRIMETHOBENZAMIDE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2011-03-08ANDA091330_001
9NDA017530TIGANPAR STERILE PRODUCTS LLCNDA017530_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA086577_001discontinuedTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1982-10-19TRIMETHOBENZAMIDE HYDROCHLORIDE
2ANDA087939_001discontinuedTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1982-12-28TRIMETHOBENZAMIDE HYDROCHLORIDE
3ANDA088804_001discontinuedTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1987-04-03TRIMETHOBENZAMIDE HYDROCHLORIDE
4ANDA088960_001discontinuedTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1986-04-04TRIMETHOBENZAMIDE HYDROCHLORIDE
5ANDA089043_001discontinuedTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1986-04-04TRIMETHOBENZAMIDE HYDROCHLORIDE
6ANDA089094_001discontinuedTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1986-04-04TRIMETHOBENZAMIDE HYDROCHLORIDE
7ANDA091329_001RXTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalseAP2011-03-08TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE
8ANDA091330_001RXTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONFalseAP2011-03-08TRIMETHOBENZAMIDE HYDROCHLORIDE
9NDA017530_001RXTRIMETHOBENZAMIDE HYDROCHLORIDE (100MG/ML)INJECTIONTrueAPTIGAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10797d0b2-a61d-4db8-a2ce-ce973a2eb064 (view SPL)Trimethobenzamide HydrochlorideprescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-07-133420230142, 420230143
230a73005-ac90-467c-bedd-59d528e7930e (view SPL)Trimethobenzamide HCL 200 mg Injection, USP 2 mL CarpujectprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-121525840952
37da90678-b229-4ad6-9193-2b8a3e9ba695 (view SPL)Tigan (trimethobenzamide hydrochloride)prescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-10-072420230119, 420230118
497191d37-7c2e-48c6-91bf-0631fd7b1dd8 (view SPL)Tigan (trimethobenzamide hydrochloride)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-271216950853
5c1d3cc1f-f990-42b1-bc42-3551c1bfa12a (view SPL)Trimethobenzamide HydrochlorideprescriptionHuman PrescriptionRemedyrepack Inc.2014-01-091521250805
6d86e48ca-7e98-4e9c-9b1e-f80fef1c7c2a (view SPL)Tigan 100 mg/mL Injection 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-021525840119

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