Ciprofloxacin Oral Suspension

Brand(s)
Cipro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2015-02-02)
Oldest Current Product
1997-09-26
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\CIPROFLOXACIN
FDAOB
ORAL\FOR SUSPENSION\CIPROFLOXACIN
SPL Active
ORAL\POWDER, FOR SUSPENSION\CIPROFLOXACIN
ORAL\SUSPENSION\CIPROFLOXACIN HYDROCHLORIDE
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\CIPROFLOXACIN
ORAL\SUSPENSION\CIPROFLOXACIN

product(s) by strength(s)

ciprofloxacin 100 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190773CiproNDABayer Healthcare Pharmaceuticals Inc.1997-09-26CIPROFLOXACIN HYDROCHLORIDEORALSUSPENSIONNDA020780888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0

ciprofloxacin 50 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190777CiproNDABayer Healthcare Pharmaceuticals Inc.1997-09-26CIPROFLOXACIN HYDROCHLORIDEORALSUSPENSIONNDA020780888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681800392ANDALupin Pharmaceuticals, Inc.2014-06-06CIPROFLOXACINORALPOWDER, FOR SUSPENSIONANDA200563f8f4461c-c9fa-451b-ba24-b080c8bfc2d7

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA200563CIPROFLOXACINLUPIN LTD2014-03-05ANDA200563_001, ANDA200563_002
2NDA020780CIPROBAYER HEALTHCARE PHARMACEUTICALS INC1997-09-26p5695784NDA020780_001, NDA020780_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200563_001RXCIPROFLOXACIN (250MG/5ML)ORALFOR SUSPENSIONFalseAB2014-03-05CIPROFLOXACIN
2ANDA200563_002RXCIPROFLOXACIN (500MG/5ML)ORALFOR SUSPENSIONFalseAB2014-03-05CIPROFLOXACIN
3NDA020780_001RXCIPROFLOXACIN (250MG/5ML)ORALFOR SUSPENSIONFalseAB1997-09-26CIPRO
4NDA020780_002RXCIPROFLOXACIN (500MG/5ML)ORALFOR SUSPENSIONTrueAB1997-09-26CIPRO

patent(s)

#idexpiration dateapplication(s)
1p5695784 (view patent)2014-12-09NDA020780

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0 (view SPL)These highlights do not include all the information needed to use CIPRO safely and effectively. See full prescribing information for CIPRO.CIPRO (ciprofloxacin hydrochloride) tablet for oral useCIPRO (ciprofloxacin hydrochloride) for oral suspensionInitial U.S. Approval: 1987prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-02-0215504190773, 504190777, 504190754, 504190758Ciprofloxacin Oral Tablet
2f8f4461c-c9fa-451b-ba24-b080c8bfc2d7 (view SPL)Ciprofloxacin for Oral SuspensionprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2014-06-033681800392

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