Thiamine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2014-06-17)
Oldest Current Product
2000-09-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\THIAMINE
FDAOB
INJECTION\INJECTION\THIAMINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\THIAMINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\THIAMINE
INTRAMUSCULAR\INJECTION, SOLUTION\THIAMINE ION

product(s) by strength(s)

thiamine 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230013ANDAApp Pharmaceuticals, Llc2000-09-01THIAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA080556c3c9db74-95d4-487c-90c3-c810786fbaec, ca4899c6-cea1-48d6-b0ae-9efcf67f6fcb
2674570196ANDAMylan Institutional Llc2013-06-04THIAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA09162312986d0e-b8bf-4338-9d85-07f973b35439

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840005ANDAGeneral Injecatables & Vaccines, Inc2010-09-01THIAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION633230013ANDA0805564a8ea036-44e8-4329-ae13-3ef4ada26dfc
2525840196ANDAGeneral Injecatables & Vaccines, Inc2013-08-21THIAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION674570196ANDA091623b61eaf72-4699-4d1a-b153-022418518508
3548682489ANDAPhysicians Total Care, Inc.2001-04-18THIAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION633230013ANDA0805567b3587a5-d4ef-4d3d-8430-cbfbaaaf4cb3
4551549372ANDACardinal Health2000-09-01THIAMINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION633230013ANDA080556b9509368-3d72-4051-a08e-81636f6318ca

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040079THIAMINE HYDROCHLORIDETrueHOSPIRA WORLDWIDE, INC1996-05-03ANDA040079_001
2ANDA080509THIAMINE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTSANDA080509_001
3ANDA080553THIAMINE HYDROCHLORIDETrueWYETH AYERST LABORATORIESANDA080553_001
4ANDA080556THIAMINE HYDROCHLORIDEFRESENIUS KABI USA LLCANDA080556_001
5ANDA080571THIAMINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA080571_001, ANDA080571_002
6ANDA080575THIAMINE HYDROCHLORIDETrueHIKMA MAPLE LTDANDA080575_001
7ANDA080667THIAMINE HYDROCHLORIDETrueLUITPOLD PHARMACEUTICALS INCANDA080667_001
8ANDA080712THIAMINE HYDROCHLORIDETrueBEL MAR LABORATORIES INCANDA080712_001
9ANDA080718THIAMINE HYDROCHLORIDETrueBEL MAR LABORATORIES INCANDA080718_001
10ANDA080770THIAMINE HYDROCHLORIDETruePARKE DAVIS DIV WARNER LAMBERT COANDA080770_001
11ANDA080853BETALIN STrueELI LILLY AND COANDA080853_001
12ANDA083534THIAMINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA083534_001, ANDA083534_002
13ANDA083775THIAMINE HYDROCHLORIDETrueDELL LABORATORIES INCANDA083775_001
14ANDA087968THIAMINE HYDROCHLORIDETrueAKORN INC1982-10-01ANDA087968_001
15ANDA091623THIAMINE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2012-06-25ANDA091623_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040079_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1996-05-03THIAMINE HYDROCHLORIDE
2ANDA080509_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
3ANDA080553_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
4ANDA080556_001RXTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONTrueAPTHIAMINE HYDROCHLORIDE
5ANDA080571_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
6ANDA080571_002discontinuedTHIAMINE HYDROCHLORIDE (200MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
7ANDA080575_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
8ANDA080667_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
9ANDA080712_001discontinuedTHIAMINE HYDROCHLORIDE (200MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
10ANDA080718_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
11ANDA080770_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
12ANDA080853_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseBETALIN S
13ANDA083534_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
14ANDA083534_002discontinuedTHIAMINE HYDROCHLORIDE (200MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
15ANDA083775_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseTHIAMINE HYDROCHLORIDE
16ANDA087968_001discontinuedTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1982-10-01THIAMINE HYDROCHLORIDE
17ANDA091623_001RXTHIAMINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseAP2012-06-25THIAMINE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112986d0e-b8bf-4338-9d85-07f973b35439 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2012-04-233674570196
24a8ea036-44e8-4329-ae13-3ef4ada26dfc (view SPL)Thiamine HCL 100 mg/mL Injection, USP 2 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-01-232525840005
37b3587a5-d4ef-4d3d-8430-cbfbaaaf4cb3 (view SPL)Thiamine HCL 100 mg/mL Injection, USP 2 mL Multi Dose VialprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-09-071548682489
4b61eaf72-4699-4d1a-b153-022418518508 (view SPL)Thiamine Hydrochloride Injection, USP200 mg/2 mL (100 mg/mL)Rx onlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-08-211525840196
5b9509368-3d72-4051-a08e-81636f6318ca (view SPL)Thiamine Hydrochloride Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-09-171551549372
6c3c9db74-95d4-487c-90c3-c810786fbaec (view SPL)Thiamine Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-01-091633230013
7ca4899c6-cea1-48d6-b0ae-9efcf67f6fcb (view SPL)Thiamine Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-06-172633230013

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