Caffeine Oral 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
ORAL SOLUTION\CAFFEINE
FDAOB
INTRAVENOUS\SOLUTION\CAFFEINE CITRATE
ORAL\SOLUTION\CAFFEINE CITRATE
SPL Active
ORAL\SOLUTION\CAFFEINE CITRATE
SPL Moiety
ORAL\SOLUTION\CAFFEINE

product(s) by strength(s)

caffeine citrate 20 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1553900358CafcitNDABedford Laboratories2008-11-042016-05-29CAFFEINE CITRATEORALSOLUTIONNDA020793fbcd234e-57e1-4da2-a96c-e3f7b7cf6ec0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1250210602ANDASagent Pharmaceuticals2012-09-15CAFFEINE CITRATEORALSOLUTIONANDA0911025f38c395-0093-4afd-89ec-f96e5dc0934a
2473350290ANDASun Pharma Global Fze2009-10-01, 2014-06-02CAFFEINE CITRATEORALSOLUTIONANDA090357cc632825-e0a4-4524-8d7d-ce926efab3d6, d06d3810-9923-4199-be5e-ee5ee086b0a4
3517540501ANDAExela Pharma Sciences, Llc2006-09-21CAFFEINE CITRATEORALSOLUTIONANDA0773045d05ebf4-fd27-3bd1-5634-b41e33abc41f
4517540503ANDAExela Pharma Sciences, Llc2006-09-21CAFFEINE CITRATEORALSOLUTIONANDA077304bd6ac18d-c65c-42bc-a3ca-7a428c13aae7
5627560290ANDASun Pharmaceutical Industries Limited2009-10-01CAFFEINE CITRATEORALSOLUTIONANDA090357dfa7e0a9-eac0-4741-9b85-69c122f13e33
6633230406ANDAApp Pharmaceuticals, Llc2009-11-19CAFFEINE CITRATEORALSOLUTIONANDA078002b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250734ANDARemedyrepack Inc.2013-10-04, 2013-10-31CAFFEINE CITRATEORALSOLUTION473350290ANDA0903570f52c2f7-15f0-4270-924d-fc2992a1e36b, 3ff5003e-7202-4606-8685-7238a23fec1e

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA077233CAFFEINE CITRATEEXELA PHARMA SCIENCES2006-09-21ANDA077233_001Caffeine Injectable Solution
2ANDA077304CAFFEINE CITRATEEXELA PHARMA SCIENCES LLC2006-09-21ANDA077304_001Caffeine Injectable Solution
3ANDA077906CAFFEINE CITRATELUITPOLD PHARMACEUTICALS INC2007-05-15ANDA077906_001Caffeine Injectable Solution
4ANDA077997CAFFEINE CITRATEFRESENIUS KABI USA LLC2007-07-20ANDA077997_001Caffeine Injectable Solution
5ANDA078002CAFFEINE CITRATEFRESENIUS KABI USA LLC2008-01-31ANDA078002_001Caffeine Injectable Solution
6ANDA090064CAFFEINE CITRATELUITPOLD PHARMACEUTICALS INC2009-11-20ANDA090064_001Caffeine Injectable Solution
7ANDA090077CAFFEINE CITRATESUN PHARMA GLOBAL FZE2009-09-30ANDA090077_001Caffeine Injectable Solution
8ANDA090357CAFFEINE CITRATESUN PHARMA GLOBAL FZE2009-09-30ANDA090357_001Caffeine Injectable Solution
9ANDA090827CAFFEINE CITRATESAGENT PHARMACEUTICALS INC2012-08-29ANDA090827_001Caffeine Injectable Solution
10ANDA091102CAFFEINE CITRATESAGENT PHARMACEUTICALS INC2012-08-29ANDA091102_001Caffeine Injectable Solution
11ANDA205013CAFFEINE CITRATEAUROBINDO PHARMA LTD2015-09-22ANDA205013_001Caffeine Injectable Solution
12NDA020793CAFCITEUROHEALTH INTERNATIONAL SARL1999-09-21NDA020793_001, NDA020793_002Caffeine Injectable 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
10f52c2f7-15f0-4270-924d-fc2992a1e36b (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-311521250734
23ff5003e-7202-4606-8685-7238a23fec1e (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-041521250734
35d05ebf4-fd27-3bd1-5634-b41e33abc41f (view SPL)prescriptionHuman PrescriptionExela Pharma Sciences, LlcMANUFACTURE2015-03-262517540501
45f38c395-0093-4afd-89ec-f96e5dc0934a (view SPL)Caffeine Citrate Injection, USPCaffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-156250210602, 250210601Caffeine Injectable Solution
5b4fb7c77-1e82-48b7-83c5-dd04ec7c5c4e (view SPL)Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2009-12-153633230406
6bd6ac18d-c65c-42bc-a3ca-7a428c13aae7 (view SPL)prescriptionHuman PrescriptionExela Pharma Sciences, Llcmanufacture2015-09-091517540503
7cc632825-e0a4-4524-8d7d-ce926efab3d6 (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-05-073473350290, 473350289Caffeine Injectable Solution
8d06d3810-9923-4199-be5e-ee5ee086b0a4 (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2014-09-201473350290, 473350289Caffeine Injectable Solution
9dfa7e0a9-eac0-4741-9b85-69c122f13e33 (view SPL)Caffeine Citrate Injection, USP Caffeine Citrate Oral Solution, USPprescriptionHuman PrescriptionSun Pharmaceutical Industries Limitedanalysis, manufacture2009-10-021627560290, 627560289Caffeine Injectable Solution
10fbcd234e-57e1-4da2-a96c-e3f7b7cf6ec0 (view SPL)CAFCIT (caffeine citrate) Injection and CAFCIT (caffeine citrate) Oral SolutionprescriptionHuman PrescriptionBedford Laboratories2014-05-274553900358, 553900357Caffeine Injectable Solution

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