ceftibuten Oral Capsule

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 CAPSULE\CEFTIBUTEN
FDAOB
ORAL\CAPSULE\CEFTIBUTEN DIHYDRATE
SPL Active
ORAL\CAPSULE\CEFTIBUTEN DIHYDRATE
SPL Moiety
ORAL\CAPSULE\CEFTIBUTEN

product(s) by strength(s)

ceftibuten 400 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1652240800CedaxNDAPernix Therapeutics, Llc1995-12-20CEFTIBUTEN DIHYDRATEORALCAPSULENDA050685756d627b-021d-4609-aa08-af6cab80a812

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1441830400NDA AUTHORIZED GENERICMacoven Pharmaceuticals2013-10-01CEFTIBUTEN DIHYDRATEORALCAPSULENDA05068513229b1a-c1db-4303-8e73-f83fa1e5677c

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050685CEDAXPERNIX THERAPEUTICS LLC1995-12-20NDA050685_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA050685_002RXCEFTIBUTEN DIHYDRATE (EQ 400MG BASE)ORALCAPSULETrue1995-12-20CEDAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
113229b1a-c1db-4303-8e73-f83fa1e5677c (view SPL)Ceftibuten CapsulesCeftibuten Oral SuspensionprescriptionHuman PrescriptionMacoven Pharmaceuticalsmanufacture2015-08-143441830400, 441830180ceftibuten Oral Suspension
22dd58c88-142f-41ad-bc31-0a4fff074970 (view SPL)CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension)prescriptionHuman PrescriptionShionogi Inc.2010-01-121596300820, 596300821ceftibuten Oral Suspension
3756d627b-021d-4609-aa08-af6cab80a812 (view SPL)CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension)prescriptionHuman PrescriptionPernix Therapeutics, Llcmanufacture2015-08-315652240800, 652240802, 652240804ceftibuten Oral Suspension

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