Cefotetan Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2015-08-28)
Oldest Current Product
2009-11-18
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\CEFOTETAN
FDAOB
INJECTION\INJECTION\CEFOTETAN DISODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN DISODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN DISODIUM
INTRAVENOUS\INJECTION, SOLUTION\CEFOTETAN DISODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN
INTRAVENOUS\INJECTION, SOLUTION\CEFOTETAN

product(s) by strength(s)

cefotetan 20 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643173ANDAB. Braun Medical Inc.2010-08-20CEFOTETAN DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA065430bc4d6887-e543-416e-9865-c0af4060af9c

cefotetan 200 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230396ANDAApp Pharmaceuticals, Llc2009-12-03CEFOTETAN DISODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA065375c6b8667e-8bb6-ea58-a969-2f74458bc611

cefotetan 40 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002643175ANDAB. Braun Medical Inc.2010-08-20CEFOTETAN DISODIUMINTRAVENOUSINJECTION, SOLUTIONANDA065430bc4d6887-e543-416e-9865-c0af4060af9c

cefotetan 400 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230385ANDAApp Pharmaceuticals, Llc2009-11-18CEFOTETAN DISODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065374bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e

cefotetan 500 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230386ANDAApp Pharmaceuticals, Llc2009-11-18CEFOTETAN DISODIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065374bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA063293CEFOTANTrueIGI LABORATORIES INC1993-04-29ANDA063293_001, ANDA063293_002
2ANDA065374CEFOTETANFRESENIUS KABI USA LLC2007-08-09ANDA065374_001, ANDA065374_002
3ANDA065375CEFOTETANFRESENIUS KABI USA LLC2007-08-09ANDA065375_001
4ANDA065430CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERB BRAUN MEDICAL INC2007-08-09ANDA065430_001, ANDA065430_002
5ANDA091030CEFOTETANWEST-WARD PHARMACEUTICAL CORP2011-10-26ANDA091030_001
6ANDA091031CEFOTETANWEST-WARD PHARMACEUTICAL CORP2011-10-26ANDA091031_001, ANDA091031_002
7NDA050588CEFOTANTrueIGI LABORATORIES INC1985-12-27NDA050588_001, NDA050588_002, NDA050588_003
8NDA050694CEFOTAN IN PLASTIC CONTAINERTrueIGI LABORATORIES INC1993-07-30NDA050694_001, NDA050694_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA063293_001discontinuedCEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1993-04-29CEFOTAN
2ANDA063293_002discontinuedCEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1993-04-29CEFOTAN
3ANDA065374_001RXCEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)INJECTIONTrueAP2007-08-09CEFOTETAN
4ANDA065374_002RXCEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)INJECTIONTrueAP2007-08-09CEFOTETAN
5ANDA065375_001RXCEFOTETAN DISODIUM (EQ 10GM BASE/VIAL)INJECTIONTrueAP2007-08-09CEFOTETAN
6ANDA065430_001RXCEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)INJECTIONTrue2007-08-09CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
7ANDA065430_002RXCEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)INJECTIONTrue2007-08-09CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
8ANDA091030_001RXCEFOTETAN DISODIUM (EQ 10GM BASE/VIAL)INJECTIONFalseAP2011-10-26CEFOTETAN
9ANDA091031_001RXCEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-10-26CEFOTETAN
10ANDA091031_002RXCEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-10-26CEFOTETAN
11NDA050588_001discontinuedCEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)INJECTIONFalse1985-12-27CEFOTAN
12NDA050588_002discontinuedCEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)INJECTIONFalse1985-12-27CEFOTAN
13NDA050588_003discontinuedCEFOTETAN DISODIUM (EQ 10GM BASE/VIAL)INJECTIONFalse1988-04-25CEFOTAN
14NDA050694_001discontinuedCEFOTETAN DISODIUM (EQ 40MG BASE/ML)INJECTIONFalse1993-07-30CEFOTAN IN PLASTIC CONTAINER
15NDA050694_002discontinuedCEFOTETAN DISODIUM (EQ 20MG BASE/ML)INJECTIONFalse1993-07-30CEFOTAN IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1bc4d6887-e543-416e-9865-c0af4060af9c (view SPL)CEFOTETAN FOR INJECTION USP AND DEXTROSE INJECTION USPprescriptionHuman PrescriptionB. Braun Medical Inc.2013-02-146002643173, 002643175
2bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e (view SPL)Cefotetan for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2015-05-204633230385, 633230386
3c6b8667e-8bb6-ea58-a969-2f74458bc611 (view SPL)Cefotetan for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2015-08-284633230396

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