ceftibuten Oral Suspension

Brand(s)
Cedax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pernix Therapeutics, Llc (2015-08-31)
Oldest Current Product
1995-12-20
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
ORAL SUSPENSION\CEFTIBUTEN
FDAOB
ORAL\FOR SUSPENSION\CEFTIBUTEN DIHYDRATE
SPL Active
ORAL\SUSPENSION\CEFTIBUTEN DIHYDRATE
SPL Moiety
ORAL\SUSPENSION\CEFTIBUTEN

product(s) by strength(s)

ceftibuten 18 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1652240802CedaxNDAPernix Therapeutics, Llc1995-12-202012-08-01CEFTIBUTEN DIHYDRATEORALSUSPENSIONNDA050686756d627b-021d-4609-aa08-af6cab80a812

ceftibuten 36 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1652240804CedaxNDAPernix Therapeutics, Llc2010-10-20CEFTIBUTEN DIHYDRATEORALSUSPENSIONNDA050686756d627b-021d-4609-aa08-af6cab80a812

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1441830180NDA AUTHORIZED GENERICMacoven Pharmaceuticals2013-10-01CEFTIBUTEN DIHYDRATEORALSUSPENSIONNDA05068613229b1a-c1db-4303-8e73-f83fa1e5677c

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050686CEDAXPERNIX THERAPEUTICS LLC1995-12-20NDA050686_001, NDA050686_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA050686_001RXCEFTIBUTEN DIHYDRATE (EQ 90MG BASE/5ML)ORALFOR SUSPENSIONTrue1995-12-20CEDAX
2NDA050686_002RXCEFTIBUTEN DIHYDRATE (EQ 180MG BASE/5ML)ORALFOR SUSPENSIONTrue1995-12-20CEDAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
113229b1a-c1db-4303-8e73-f83fa1e5677c (view SPL)Ceftibuten CapsulesCeftibuten Oral SuspensionprescriptionHuman PrescriptionMacoven Pharmaceuticalsmanufacture2015-08-143441830180, 441830400ceftibuten Oral Capsule
22dd58c88-142f-41ad-bc31-0a4fff074970 (view SPL)CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension)prescriptionHuman PrescriptionShionogi Inc.2010-01-121596300820, 596300821ceftibuten Oral Capsule
3756d627b-021d-4609-aa08-af6cab80a812 (view SPL)CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension)prescriptionHuman PrescriptionPernix Therapeutics, Llcmanufacture2015-08-315652240802, 652240804, 652240800ceftibuten Oral Capsule

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