Application 076089

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACINCIPROFLOXACINTABLET; ORAL100MGNoNo
002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo
003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo
004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 750MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-5312CiprofloxacinCiprofloxacinTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-606Ciprofloxacin hydrochlorideCiprofloxacin hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
53808-0223Ciprofloxacin hydrochlorideCiprofloxacin hydrochlorideState of Florida DOH Central PharmacyANDACurrent
66116-508Ciprofloxacin HydrochlorideCiprofloxacin HydrochlorideMedVantx, Inc.ANDACurrent
67296-0543CIPROFLOXACIN HYDROCHLORIDEciprofloxacin hydrochloride tabletRedPharm Drug Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31073ORIG2004-06-15