Caffeine Injectable Solution

Brand(s)
Cafcit
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bedford Laboratories (2014-05-27)
Oldest Current Product
2006-09-21
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CAFFEINE
FDAOB
INTRAVENOUS\SOLUTION\CAFFEINE CITRATE
ORAL\SOLUTION\CAFFEINE CITRATE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\CAFFEINE CITRATE
INTRAVENOUS\INJECTION\CAFFEINE CITRATE
INTRAVENOUS\SOLUTION\CAFFEINE CITRATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\CAFFEINE
INTRAVENOUS\INJECTION\CAFFEINE
INTRAVENOUS\SOLUTION\CAFFEINE

product(s) by strength(s)

caffeine citrate 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1553900357CafcitNDABedford Laboratories2008-11-042016-04-30CAFFEINE CITRATEINTRAVENOUSINJECTIONNDA020793fbcd234e-57e1-4da2-a96c-e3f7b7cf6ec0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170020ANDAAmerican Regent, Inc.2007-09-10CAFFEINE CITRATEINTRAVENOUSINJECTION, SOLUTIONANDA077906d17e3be5-514f-454a-8347-d804cd5ec37f
2250210601ANDASagent Pharmaceuticals2012-09-15CAFFEINE CITRATEINTRAVENOUSSOLUTIONANDA0908275f38c395-0093-4afd-89ec-f96e5dc0934a
3473350289ANDASun Pharma Global Fze2009-10-01, 2014-06-05CAFFEINE CITRATEINTRAVENOUSINJECTIONANDA090077cc632825-e0a4-4524-8d7d-ce926efab3d6, d06d3810-9923-4199-be5e-ee5ee086b0a4
4517540500ANDAExela Pharma Sciences, Llc2006-09-21CAFFEINE CITRATEINTRAVENOUSINJECTIONANDA077233f423a220-e7bf-4d24-bc52-bafc1864265b
5517540502ANDAExela Pharma Sciences, Llc2006-09-21CAFFEINE CITRATEINTRAVENOUSINJECTIONANDA0772336de25a89-23b3-41e3-91aa-d86ca83686d4
6551500187ANDAAuromedics Pharma Llc2015-09-22CAFFEINE CITRATEINTRAVENOUSINJECTION, SOLUTIONANDA2050138ef448ca-5549-4272-a6b4-5c4f57653c4c
7627560289ANDASun Pharmaceutical Industries Limited2009-10-01CAFFEINE CITRATEINTRAVENOUSINJECTIONANDA090077dfa7e0a9-eac0-4741-9b85-69c122f13e33
8633230407ANDAApp Pharmaceuticals, Llc2009-11-19CAFFEINE CITRATEINTRAVENOUSINJECTION, SOLUTIONANDA07799738b39044-737a-4247-a6c4-c86f5e92490e, baf9f88a-776a-44e7-82cc-8f0ca419572f

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA077233CAFFEINE CITRATEEXELA PHARMA SCIENCES2006-09-21ANDA077233_001Caffeine Oral Solution
2ANDA077304CAFFEINE CITRATEEXELA PHARMA SCIENCES LLC2006-09-21ANDA077304_001Caffeine Oral Solution
3ANDA077906CAFFEINE CITRATELUITPOLD PHARMACEUTICALS INC2007-05-15ANDA077906_001Caffeine Oral Solution
4ANDA077997CAFFEINE CITRATEFRESENIUS KABI USA LLC2007-07-20ANDA077997_001Caffeine Oral Solution
5ANDA078002CAFFEINE CITRATEFRESENIUS KABI USA LLC2008-01-31ANDA078002_001Caffeine Oral Solution
6ANDA090064CAFFEINE CITRATELUITPOLD PHARMACEUTICALS INC2009-11-20ANDA090064_001Caffeine Oral Solution
7ANDA090077CAFFEINE CITRATESUN PHARMA GLOBAL FZE2009-09-30ANDA090077_001Caffeine Oral Solution
8ANDA090357CAFFEINE CITRATESUN PHARMA GLOBAL FZE2009-09-30ANDA090357_001Caffeine Oral Solution
9ANDA090827CAFFEINE CITRATESAGENT PHARMACEUTICALS INC2012-08-29ANDA090827_001Caffeine Oral Solution
10ANDA091102CAFFEINE CITRATESAGENT PHARMACEUTICALS INC2012-08-29ANDA091102_001Caffeine Oral Solution
11ANDA205013CAFFEINE CITRATEAUROBINDO PHARMA LTD2015-09-22ANDA205013_001Caffeine Oral Solution
12NDA020793CAFCITEUROHEALTH INTERNATIONAL SARL1999-09-21NDA020793_001, NDA020793_002Caffeine Oral Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077233_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)INTRAVENOUSSOLUTIONFalseAP2006-09-21CAFFEINE CITRATE
2ANDA077304_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)ORALSOLUTIONFalseAA2006-09-21CAFFEINE CITRATE
3ANDA077906_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)INTRAVENOUSSOLUTIONFalseAP2007-05-15CAFFEINE CITRATE
4ANDA077997_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)INTRAVENOUSSOLUTIONFalseAP2007-07-20CAFFEINE CITRATE
5ANDA078002_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)ORALSOLUTIONFalseAA2008-01-31CAFFEINE CITRATE
6ANDA090064_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)ORALSOLUTIONFalseAA2009-11-20CAFFEINE CITRATE
7ANDA090077_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)INTRAVENOUSSOLUTIONFalseAP2009-09-30CAFFEINE CITRATE
8ANDA090357_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)ORALSOLUTIONFalseAA2009-09-30CAFFEINE CITRATE
9ANDA090827_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)INTRAVENOUSSOLUTIONFalseAP2012-08-29CAFFEINE CITRATE
10ANDA091102_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)ORALSOLUTIONFalseAA2012-08-29CAFFEINE CITRATE
11ANDA205013_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)INTRAVENOUSSOLUTIONFalseAP2015-09-22CAFFEINE CITRATE
12NDA020793_001RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)INTRAVENOUSSOLUTIONTrueAP1999-09-21CAFCIT
13NDA020793_002RXCAFFEINE CITRATE (EQ 30MG BASE/3ML)ORALSOLUTIONTrueAA2000-04-12CAFCIT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
121489401-f2a7-47d3-897a-4b7efa04dd7a (view SPL)CAFCITInjection (caffeine citrate injection, USP)prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2015-03-101006416164
238b39044-737a-4247-a6c4-c86f5e92490e (view SPL)Caffeine Citrate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-07-291633230407
35f38c395-0093-4afd-89ec-f96e5dc0934a (view SPL)Caffeine Citrate Injection, USPCaffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-156250210601, 250210602Caffeine Oral Solution
46de25a89-23b3-41e3-91aa-d86ca83686d4 (view SPL)prescriptionHuman PrescriptionExela Pharma Sciences, Llcmanufacture2015-09-091517540502
58ef448ca-5549-4272-a6b4-5c4f57653c4c (view SPL)prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, MANUFACTURE2015-10-011551500187
6baf9f88a-776a-44e7-82cc-8f0ca419572f (view SPL)Caffeine Citrate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-11-074633230407
7cc632825-e0a4-4524-8d7d-ce926efab3d6 (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-05-073473350289, 473350290Caffeine Oral Solution
8d06d3810-9923-4199-be5e-ee5ee086b0a4 (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2014-09-201473350289, 473350290Caffeine Oral Solution
9d17e3be5-514f-454a-8347-d804cd5ec37f (view SPL)CAFFEINE CITRATE INJECTION, USPprescriptionHuman PrescriptionAmerican Regent, Inc.2011-10-081005170020
10dfa7e0a9-eac0-4741-9b85-69c122f13e33 (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSun Pharmaceutical Industries Limitedanalysis, manufacture2009-10-021627560289, 627560290Caffeine Oral Solution
11f423a220-e7bf-4d24-bc52-bafc1864265b (view SPL)Caffeine Citrate Injection, USPprescriptionHuman PrescriptionExela Pharma Sciences, Llc2014-12-011517540500
12fbcd234e-57e1-4da2-a96c-e3f7b7cf6ec0 (view SPL)CAFCIT (caffeine citrate) Injection and CAFCIT (caffeine citrate) Oral SolutionprescriptionHuman PrescriptionBedford Laboratories2014-05-274553900357, 553900358Caffeine Oral Solution

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