Vitamin B 12 Injectable Solution

Category(s)
other, prescription
SPL Type(s)
Dietary Supplement, Human Prescription
Master SPL
Oaklock, Llc (2015-07-08)
Oldest Current Product
1990-09-30
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\VITAMIN B 12
FDAOB
INJECTION\INJECTION\CYANOCOBALAMIN\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\CYANOCOBALAMIN
INTRAMUSCULAR\INJECTION\CYANOCOBALAMIN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\CYANOCOBALAMIN
INTRAMUSCULAR\INJECTION\CYANOCOBALAMIN

product(s) by strength(s)

vitamin b 12 1 mg/ml injectable solution

original product(s)(s)

#idlabelerfirst marketedactive ingredient(s)routedose formspl
1612330110Phoenix Labs, Inc.2013-12-23CYANOCOBALAMININTRAMUSCULARINJECTION6faab145-0103-45d4-9091-d3ed8827b8b4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170031ANDAAmerican Regent, Inc.1990-09-30CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTIONANDA0807372fb653d6-e2b2-4969-831b-c0dc37b9c0cc
2005170032ANDAAmerican Regent, Inc.1996-11-07CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTIONANDA0807372fb653d6-e2b2-4969-831b-c0dc37b9c0cc
3005170130ANDAAmerican Regent, Inc.2003-05-29CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTIONANDA0807372fb653d6-e2b2-4969-831b-c0dc37b9c0cc
4633230044ANDAApp Pharmaceuticals, Llc2000-10-18CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTIONANDA080557acff4ff3-4435-4995-a117-dbfcdf72334a
5692630816ANDAOaklock, Llc2015-06-19ANDA0805578eb9d795-dbf5-4080-94fc-5d7fe2323435
6692630819ANDAOaklock, Llc2015-07-08ANDA080737d1a740d5-ef9f-4369-b429-0b6f823543ea

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840032ANDAGeneral Injecatables & Vaccines, Inc2010-03-01CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTION005170032ANDA08073700bdb9f4-94b3-46dc-a6fb-56dd7b7f768a
2525840130ANDAGeneral Injecatables & Vaccines, Inc2010-07-01CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTION005170130ANDA08073774141034-87b2-4401-b100-44aee4849fe8
3548680762ANDAPhysicians Total Care, Inc.2003-09-18CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTION005170031ANDA08073796edc686-afea-47e1-adf2-e3d478125b96
4551545729ANDACardinal Health2003-05-29CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTION005170130ANDA0807378e71fdb7-b7bf-4228-88e2-b9922b5c5de5
5551545740ANDACardinal Health1990-09-30CYANOCOBALAMININTRAMUSCULARINJECTION, SOLUTION005170031ANDA0807378e71fdb7-b7bf-4228-88e2-b9922b5c5de5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040451CYANOCOBALAMINTrueMYLAN INSTITUTIONAL LLC2003-09-23ANDA040451_001
2ANDA080510CYANOCOBALAMINTrueABRAXIS PHARMACEUTICAL PRODUCTSANDA080510_001, ANDA080510_002, ANDA080510_003
3ANDA080515CYANOCOBALAMINTrueEUROHEALTH INTERNATIONAL SARLANDA080515_002
4ANDA080554CYANOCOBALAMINTrueWYETH AYERST LABORATORIESANDA080554_001, ANDA080554_002
5ANDA080557CYANOCOBALAMINFRESENIUS KABI USA LLCANDA080557_002, ANDA080557_003
6ANDA080564CYANOCOBALAMINTrueSANOFI AVENTIS US LLCANDA080564_001
7ANDA080570RUVITETrueSAVAGE LABORATORIES INC DIV ALTANA INCANDA080570_002
8ANDA080573CYANOCOBALAMINTrueWATSON LABORATORIES INCANDA080573_001, ANDA080573_002
9ANDA080668CYANOCOBALAMINTrueLUITPOLD PHARMACEUTICALS INCANDA080668_001
10ANDA080689CYANOCOBALAMINTrueDELL LABORATORIES INCANDA080689_001, ANDA080689_002, ANDA080689_003
11ANDA080737CYANOCOBALAMINLUITPOLD PHARMACEUTICALS INCANDA080737_001
12ANDA080855BETALIN 12TrueELI LILLY AND COANDA080855_001, ANDA080855_002
13ANDA083013COBAVITETrueWATSON LABORATORIES INCANDA083013_001
14ANDA083064COBAVITETrueWATSON LABORATORIES INCANDA083064_001
15ANDA083075CYANOCOBALAMINTrueLYPHOMED DIV FUJISAWA USA INCANDA083075_001
16ANDA083120CYANOCOBALAMINTrueWATSON LABORATORIES INCANDA083120_001, ANDA083120_002
17ANDA087551CYANOCOBALAMINTrueSOLOPAK MEDICAL PRODUCTS INC1984-02-29ANDA087551_001
18ANDA087969CYANOCOBALAMINTrueAKORN INC1983-11-10ANDA087969_001
19NDA006668REDISOLTrueMERCK AND CO INCNDA006668_010
20NDA006798BERUBIGENTruePHARMACIA AND UPJOHN CONDA006798_001
21NDA006799RUBRAMIN PCTrueBRISTOL MYERS SQUIBB CONDA006799_002, NDA006799_004, NDA006799_010
22NDA007012VI-TWELTrueBAYER HEALTHCARE PHARMACEUTICALS INCNDA007012_002
23NDA007085CYANOCOBALAMINTrueWARNER CHILCOTT INCNDA007085_002
24NDA010791RUBIVITETrueBEL MAR LABORATORIES INCNDA010791_001, NDA010791_002, NDA010791_003, NDA010791_004, NDA010791_005

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040451_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalse2003-09-23CYANOCOBALAMIN
2ANDA080510_001discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseCYANOCOBALAMIN
3ANDA080510_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
4ANDA080510_003discontinuedCYANOCOBALAMIN (0.03MG/ML)INJECTIONFalseCYANOCOBALAMIN
5ANDA080515_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
6ANDA080554_001discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseCYANOCOBALAMIN
7ANDA080554_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
8ANDA080557_002discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseCYANOCOBALAMIN
9ANDA080557_003RXCYANOCOBALAMIN (1MG/ML)INJECTIONTrueAPCYANOCOBALAMIN
10ANDA080564_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
11ANDA080570_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseRUVITE
12ANDA080573_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
13ANDA080573_002discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseCYANOCOBALAMIN
14ANDA080668_001discontinuedCYANOCOBALAMIN (0.03MG/ML)INJECTIONFalseCYANOCOBALAMIN
15ANDA080689_001discontinuedCYANOCOBALAMIN (0.03MG/ML)INJECTIONFalseCYANOCOBALAMIN
16ANDA080689_002discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseCYANOCOBALAMIN
17ANDA080689_003discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
18ANDA080737_001RXCYANOCOBALAMIN (1MG/ML)INJECTIONTrueAPCYANOCOBALAMIN
19ANDA080855_001discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseBETALIN 12
20ANDA080855_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseBETALIN 12
21ANDA083013_001discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseCOBAVITE
22ANDA083064_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCOBAVITE
23ANDA083075_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
24ANDA083120_001discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseCYANOCOBALAMIN
25ANDA083120_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
26ANDA087551_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalse1984-02-29CYANOCOBALAMIN
27ANDA087969_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalse1983-11-10CYANOCOBALAMIN
28NDA006668_010discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseREDISOL
29NDA006798_001discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseBERUBIGEN
30NDA006799_002discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseRUBRAMIN PC
31NDA006799_004discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseRUBRAMIN PC
32NDA006799_010discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalse1988-04-28RUBRAMIN PC
33NDA007012_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseVI-TWEL
34NDA007085_002discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseCYANOCOBALAMIN
35NDA010791_001discontinuedCYANOCOBALAMIN (0.05MG/ML)INJECTIONFalseRUBIVITE
36NDA010791_002discontinuedCYANOCOBALAMIN (0.1MG/ML)INJECTIONFalseRUBIVITE
37NDA010791_003discontinuedCYANOCOBALAMIN (1MG/ML)INJECTIONFalseRUBIVITE
38NDA010791_004discontinuedCYANOCOBALAMIN (0.03MG/ML)INJECTIONFalseRUBIVITE
39NDA010791_005discontinuedCYANOCOBALAMIN (0.12MG/ML)INJECTIONFalseRUBIVITE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100bdb9f4-94b3-46dc-a6fb-56dd7b7f768a (view SPL)Cyanocobalamin 1000mcg/ml Injection USP 10ml Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-07-131525840032
22fb653d6-e2b2-4969-831b-c0dc37b9c0cc (view SPL)CYANOCOBALAMININJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, STERILIZE2014-04-175005170031, 005170032, 005170130
36faab145-0103-45d4-9091-d3ed8827b8b4 (view SPL)otherDietary SupplementPhoenix Labs, Inc.manufacture2013-12-191612330110
474141034-87b2-4401-b100-44aee4849fe8 (view SPL)Cyanocobalamin 1000mcg/mL Injection, USP 30 mL Multi-Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-07-291525840130
58e71fdb7-b7bf-4228-88e2-b9922b5c5de5 (view SPL)CYANOCOBALAMIN INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-04-232551545729, 551545740
68eb9d795-dbf5-4080-94fc-5d7fe2323435 (view SPL)prescriptionHuman PrescriptionOaklock, Llc2015-06-191692630816
796edc686-afea-47e1-adf2-e3d478125b96 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-07-011548680762
8acff4ff3-4435-4995-a117-dbfcdf72334a (view SPL)Cyanocobalamin Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-01-171633230044
9d1a740d5-ef9f-4369-b429-0b6f823543ea (view SPL)prescriptionHuman PrescriptionOaklock, Llc2015-07-081692630819
10d8d9a067-438f-4095-8500-903f3e47f274 (view SPL)otherDietary SupplementPhoenix Meds, Inc.manufacture2014-09-033690290110

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