Vitamin B6 Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2015-03-06)
Oldest Current Product
1972-08-14
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\VITAMIN B6
FDAOB
INJECTION\INJECTION\PYRIDOXINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PYRIDOXINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PYRIDOXINE

product(s) by strength(s)

vitamin b6 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230180ANDAApp Pharmaceuticals, Llc1972-08-14PYRIDOXINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA080618a56d11c0-b033-4201-85ff-fc710506481a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA080572PYRIDOXINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA080572_001
2ANDA080581PYRIDOXINE HYDROCHLORIDETrueELKINS SINN DIV AH ROBINS CO INCANDA080581_001
3ANDA080618PYRIDOXINE HYDROCHLORIDEFRESENIUS KABI USA LLCANDA080618_001
4ANDA080669PYRIDOXINE HYDROCHLORIDETrueLUITPOLD PHARMACEUTICALS INCANDA080669_001
5ANDA080761PYRIDOXINE HYDROCHLORIDETrueBEL MAR LABORATORIES INCANDA080761_001
6ANDA080854HEXA-BETALINTrueELI LILLY AND COANDA080854_001
7ANDA083760PYRIDOXINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA083760_001
8ANDA083771PYRIDOXINE HYDROCHLORIDETrueDELL LABORATORIES INCANDA083771_001
9ANDA083772PYRIDOXINE HYDROCHLORIDETrueDELL LABORATORIES INCANDA083772_001
10ANDA087967PYRIDOXINE HYDROCHLORIDETrueAKORN INC1982-10-01ANDA087967_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA080572_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePYRIDOXINE HYDROCHLORIDE
2ANDA080581_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePYRIDOXINE HYDROCHLORIDE
3ANDA080618_001RXPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONTruePYRIDOXINE HYDROCHLORIDE
4ANDA080669_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePYRIDOXINE HYDROCHLORIDE
5ANDA080761_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePYRIDOXINE HYDROCHLORIDE
6ANDA080854_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalseHEXA-BETALIN
7ANDA083760_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePYRIDOXINE HYDROCHLORIDE
8ANDA083771_001discontinuedPYRIDOXINE HYDROCHLORIDE (50MG/ML)INJECTIONFalsePYRIDOXINE HYDROCHLORIDE
9ANDA083772_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalsePYRIDOXINE HYDROCHLORIDE
10ANDA087967_001discontinuedPYRIDOXINE HYDROCHLORIDE (100MG/ML)INJECTIONFalse1982-10-01PYRIDOXINE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a56d11c0-b033-4201-85ff-fc710506481a (view SPL)Pyridoxine Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-03-062633230180

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