Hydroxocobalamin Injectable Solution

Brand(s)
Cyanokit
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
U.S. Army Medical Research And Development Command (Mcmr-Rcq-Hr) (2011-04-08)
Oldest Current Product
2010-11-12
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\HYDROXOCOBALAMIN
FDAOB
INJECTION\INJECTION\HYDROXOCOBALAMIN\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\HYDROXOCOBALAMIN ACETATE
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HYDROXOCOBALAMIN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\HYDROXOCOBALAMIN
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HYDROXOCOBALAMIN

product(s) by strength(s)

hydroxocobalamin 1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912888ANDAWatson Laboratories, Inc.2010-11-12HYDROXOCOBALAMIN ACETATEINTRAMUSCULARINJECTION, SOLUTIONANDA085998a3087a39-f218-4f16-a1e7-17c39bb2eb69

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250799ANDARemedyrepack Inc.2013-12-31HYDROXOCOBALAMIN ACETATEINTRAMUSCULARINJECTION, SOLUTION005912888ANDA085998a241984e-7824-4e73-9095-bba28f779591, d35ad609-70d3-4eb2-8276-c9631ca815d1

hydroxocobalamin 25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1117040370CyanokitNDAU.S. Army Medical Research And Development Command (Mcmr-Rcq-Hr)2011-10-01HYDROXOCOBALAMININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0220414368656c-6c2b-474c-6144-4f532d424646

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA080778ALPHAREDISOLTrueMERCK AND CO INCANDA080778_001Sumatriptan Auto-Injector
2ANDA084629HYDROXOMINTrueBEL MAR LABORATORIES INCANDA084629_001Sumatriptan Auto-Injector
3ANDA084921HYDROXOCOBALAMINTrueABRAXIS PHARMACEUTICAL PRODUCTSANDA084921_001Sumatriptan Auto-Injector
4ANDA085528HYDROXOCOBALAMINTrueWATSON LABORATORIES INCANDA085528_001Sumatriptan Auto-Injector
5ANDA085998HYDROXOCOBALAMINWATSON LABORATORIES INCANDA085998_001Sumatriptan Auto-Injector
6NDA022041CYANOKITSERB SAS2006-12-15p5834448, TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING, SUBSTANCENDA022041_001, NDA022041_002Sumatriptan Auto-Injector

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA080778_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseALPHAREDISOL
2ANDA084629_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseHYDROXOMIN
3ANDA084921_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseHYDROXOCOBALAMIN
4ANDA085528_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseHYDROXOCOBALAMIN
5ANDA085998_001RXHYDROXOCOBALAMIN (1MG/ML)INJECTIONTrueHYDROXOCOBALAMIN
6NDA022041_001RXHYDROXOCOBALAMIN (5GM/VIAL)INJECTIONTrue2011-04-08CYANOKIT
7NDA022041_002discontinuedHYDROXOCOBALAMIN (2.5GM/VIAL)INJECTIONFalse2006-12-15CYANOKIT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5834448 (view patent)2016-11-14NDA022041Sumatriptan Auto-Injector

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1416c7978-5661-6e63-6546-6f7265766572 (view SPL)These highlights do not include all the information needed to use Cyanokit safely and effectively. See full prescribing information for Cyanokit.Cyanokit (hydroxocobalamin for injection) 5g for intravenous infusionInitial U.S. Approval: 1975prescriptionHuman PrescriptionU.S. Army Medical Research And Development Command (Mcmr-Rcq-Hr)MANUFACTURE, RELABEL, REPACK2011-04-197117040270
24368656c-6c2b-474c-6144-4f532d424646 (view SPL)These highlights do not include all the information needed to use Cyanokit safely and effectively. See full prescribing information for Cyanokit.Cyanokit (hydroxocobalamin for injection) 5g for intravenous infusion Initial U.S. Approval: 1975prescriptionHuman PrescriptionU.S. Army Medical Research And Development Command (Mcmr-Rcq-Hr)MANUFACTURE, RELABEL, REPACK2011-04-084117040370
3a241984e-7824-4e73-9095-bba28f779591 (view SPL)HYDROXOCOBALAMIN INJECTION USP Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-311521250799
4a3087a39-f218-4f16-a1e7-17c39bb2eb69 (view SPL)HYDROXOCOBALAMIN INJECTION USP Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-08-312005912888
5d35ad609-70d3-4eb2-8276-c9631ca815d1 (view SPL)HYDROXOCOBALAMIN INJECTION USP Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-312521250799

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