FDA.reportPublic FDA data

Application 080737

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYANOCOBALAMINCYANOCOBALAMININJECTABLE;INJECTION1MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0031CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0031CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0031CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0032CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0032CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0032CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0130CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0130CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
0517-0130CyanocobalamincyanocobalaminAmerican Regent, Inc.ANDACurrent
49836-527B-12 ComplianceCyanocobalamin, Isopropyl AlcoholRX PHARMA-PACK, INC.ANDACurrent
49836-527B-12 ComplianceCyanocobalamin, Isopropyl AlcoholRX PHARMA-PACK, INC.ANDACurrent
49836-527B-12 ComplianceCyanocobalamin, Isopropyl AlcoholRX PHARMA-PACK, INC.ANDACurrent
49836-527B-12 ComplianceCyanocobalamin, Isopropyl AlcoholRX PHARMA-PACK, INC.ANDACurrent
51662-1440CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1440CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-130CyanocobalaminCyanocobalaminGeneral Injectables & Vaccines, IncANDACurrent
68001-542CyanocobalaminCyanocobalaminBluePoint LaboratoriesANDACurrent
69263-819B12 Inject KitCyanocobalaminOaklock, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68277SUPPL2021-08-04
68240SUPPL2021-08-02