Cefotaxime Injectable Solution

Brand(s)
Claforan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-04-30)
Oldest Current Product
1981-03-11
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CEFOTAXIME
FDAOB
INJECTION\INJECTION\CEFOTAXIME SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION\CEFOTAXIME SODIUM
INTRAVENOUS\INJECTION\CEFOTAXIME SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION\CEFOTAXIME
INTRAVENOUS\INJECTION\CEFOTAXIME

product(s) by strength(s)

cefotaxime 200 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000390020ClaforanNDASanofi-Aventis U.S. Llc1981-03-11CEFOTAXIME SODIUMINTRAMUSCULARINJECTIONNDA05054706de783b-0762-4031-991e-2e726da33e16

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439935ANDAWest-Ward Pharmaceutical Corp2002-11-20CEFOTAXIME SODIUMINTRAVENOUSINJECTIONANDA065071ef1a6dc6-bc3d-4f09-8f92-7ff328f56561

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA062659CLAFORANSANOFI AVENTIS US LLC1987-01-13ANDA062659_001, ANDA062659_002Cefotaxime Injection
2ANDA064200CEFOTAXIMETrueFRESENIUS KABI USA LLC2000-03-24ANDA064200_001, ANDA064200_002, ANDA064200_003Cefotaxime Injection
3ANDA064201CEFOTAXIMETrueFRESENIUS KABI USA LLC2000-03-24ANDA064201_001, ANDA064201_002Cefotaxime Injection
4ANDA065071CEFOTAXIMEHIKMA FARMACEUTICA LDA2002-11-20ANDA065071_001Cefotaxime Injection
5ANDA065072CEFOTAXIMEHIKMA FARMACEUTICA LDA2002-11-20ANDA065072_001, ANDA065072_002, ANDA065072_003Cefotaxime Injection
6ANDA065124CEFOTAXIME SODIUMLUPIN LTD2003-09-24ANDA065124_001, ANDA065124_002, ANDA065124_003Cefotaxime Injection
7ANDA065197CEFOTAXIMEWOCKHARDT LTD2006-08-29ANDA065197_001, ANDA065197_002, ANDA065197_003Cefotaxime Injection
8ANDA065290CEFOTAXIME SODIUMHOSPIRA INC2006-08-11ANDA065290_001, ANDA065290_002, ANDA065290_003Cefotaxime Injection
9ANDA065292CEFOTAXIME SODIUMHOSPIRA INC2006-08-10ANDA065292_001Cefotaxime Injection
10ANDA065293CEFOTAXIME SODIUMHOSPIRA INC2006-08-10ANDA065293_001, ANDA065293_002Cefotaxime Injection
11ANDA065348CEFOTAXIME SODIUMTrueCEPHAZONE PHARMA LLC2010-01-25ANDA065348_001Cefotaxime Injection
12ANDA065516CEFOTAXIME SODIUMTrueAUROBINDO PHARMA LTD2009-11-06ANDA065516_001Cefotaxime Injection
13ANDA065517CEFOTAXIME SODIUMTrueAUROBINDO PHARMA LTD2009-11-06ANDA065517_001, ANDA065517_002, ANDA065517_003Cefotaxime Injection
14NDA050547CLAFORANSANOFI AVENTIS US LLCNDA050547_001, NDA050547_002, NDA050547_003, NDA050547_004Cefotaxime Injection
15NDA050596CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINERSANOFI AVENTIS US LLC1985-05-20NDA050596_001, NDA050596_002, NDA050596_003, NDA050596_004Cefotaxime Injection
16NDA050792CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINERTrueB BRAUN MEDICAL INC2004-07-29NDA050792_001, NDA050792_002Cefotaxime Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062659_001RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP1987-01-13CLAFORAN
2ANDA062659_002RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP1987-01-13CLAFORAN
3ANDA064200_001discontinuedCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
4ANDA064200_002discontinuedCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
5ANDA064200_003discontinuedCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
6ANDA064201_001discontinuedCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
7ANDA064201_002discontinuedCEFOTAXIME SODIUM (EQ 20GM BASE/VIAL)INJECTIONFalse2000-03-24CEFOTAXIME
8ANDA065071_001RXCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
9ANDA065072_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
10ANDA065072_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
11ANDA065072_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2002-11-20CEFOTAXIME
12ANDA065124_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2003-09-24CEFOTAXIME SODIUM
13ANDA065124_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2003-09-24CEFOTAXIME SODIUM
14ANDA065124_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2003-09-24CEFOTAXIME SODIUM
15ANDA065197_001RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-08-29CEFOTAXIME
16ANDA065197_002RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2008-06-20CEFOTAXIME
17ANDA065197_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2008-06-20CEFOTAXIME
18ANDA065290_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2006-08-11CEFOTAXIME SODIUM
19ANDA065290_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-08-11CEFOTAXIME SODIUM
20ANDA065290_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2006-08-11CEFOTAXIME SODIUM
21ANDA065292_001RXCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2006-08-10CEFOTAXIME SODIUM
22ANDA065293_001RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2006-08-10CEFOTAXIME SODIUM
23ANDA065293_002RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2006-08-10CEFOTAXIME SODIUM
24ANDA065348_001discontinuedCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2010-01-25CEFOTAXIME SODIUM
25ANDA065516_001discontinuedCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
26ANDA065517_001discontinuedCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
27ANDA065517_002discontinuedCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
28ANDA065517_003discontinuedCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse2009-11-06CEFOTAXIME SODIUM
29NDA050547_001RXCEFOTAXIME SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAPCLAFORAN
30NDA050547_002RXCEFOTAXIME SODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAPCLAFORAN
31NDA050547_003RXCEFOTAXIME SODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAPCLAFORAN
32NDA050547_004RXCEFOTAXIME SODIUM (EQ 10GM BASE/VIAL)INJECTIONTrueAP1983-12-29CLAFORAN
33NDA050596_001discontinuedCEFOTAXIME SODIUM (EQ 20MG BASE/ML)INJECTIONFalse1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
34NDA050596_002RXCEFOTAXIME SODIUM (EQ 20MG BASE/ML)INJECTIONTrue1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
35NDA050596_003discontinuedCEFOTAXIME SODIUM (EQ 40MG BASE/ML)INJECTIONFalse1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
36NDA050596_004RXCEFOTAXIME SODIUM (EQ 40MG BASE/ML)INJECTIONTrue1985-05-20CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
37NDA050792_001discontinuedCEFOTAXIME SODIUM (EQ 2GM BASE)INJECTIONFalse2004-07-29CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
38NDA050792_002discontinuedCEFOTAXIME SODIUM (EQ 1GM BASE)INJECTIONFalse2004-07-29CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
106de783b-0762-4031-991e-2e726da33e16 (view SPL)CLAFORAN Sterile (cefotaxime for injection, USP) and Injection (cefotaxime injection, USP)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-04-3010000390020, 000390017, 000390018, 000390019, 000390023, 000390024, 000390037, 000390038Cefotaxime Injection
2ef1a6dc6-bc3d-4f09-8f92-7ff328f56561 (view SPL)Cefotaxime for Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2014-07-307001439935

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