FDA.reportPublic FDA data

Application 076794

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo
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
10544-147CiprofloxacinCiprofloxacinBlenheim Pharmacal, Inc.ANDACurrent
11819-323Ciprofloxacinciprofloxacin hydrochlorideHHS/Program Support Center/Supply Service CenterANDACurrent
11819-351Ciprofloxacinciprofloxacin hydrochlorideHHS/Program Support Center/Supply Service CenterANDACurrent
16252-514CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-514CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-514CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-514CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-514CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-514CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-514CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-515CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-515CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-515CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-515CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-515CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-515CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-515CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-516CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-516CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-516CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-516CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-516CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-516CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
16252-516CiprofloxacinCiprofloxacinActavis Pharma, Inc.ANDACurrent
21695-210Ciprofloxacinciprofloxacin hydrochlorideRebel Distributors Corp.ANDACurrent
21695-411Ciprofloxacinciprofloxacin hydrochlorideRebel Distributors CorpANDACurrent
42708-002CiprofloxacinCiprofloxacinQPharma IncANDACurrent
42708-002CiprofloxacinCiprofloxacinQPharma IncANDACurrent
42708-002CiprofloxacinCiprofloxacinQPharma IncANDACurrent
42708-002CiprofloxacinCiprofloxacinQPharma IncANDACurrent
50090-1685CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-1685CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-1685CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-5382CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50436-6041CiprofloxacinCiprofloxacinUnit Dose ServicesANDACurrent
52959-730Ciprofloxacinciprofloxacin hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
52959-734Ciprofloxacinciprofloxacin hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
52959-739Ciprofloxacinciprofloxacin hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53401-005ciprofloxacin hydrochlorideciprofloxacin hydrochlorideTestpak Holding CompanyANDACurrent
53808-0349Ciprofloxacinciprofloxacin hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55154-2081Ciprofloxacinciprofloxacin hydrochlorideCardinal HealthANDACurrent
55154-2081Ciprofloxacinciprofloxacin hydrochlorideCardinal HealthANDACurrent
55154-2081Ciprofloxacinciprofloxacin hydrochlorideCardinal HealthANDACurrent
55154-2086Ciprofloxacinciprofloxacin hydrochlorideCardinal HealthANDACurrent
55154-2086Ciprofloxacinciprofloxacin hydrochlorideCardinal HealthANDACurrent
55154-2086Ciprofloxacinciprofloxacin hydrochlorideCardinal HealthANDACurrent
67296-0580Ciprofloxacinciprofloxacin hydrochlorideRedPharm Drug Inc.ANDACurrent
67296-0608Ciprofloxacinciprofloxacin hydrochlorideRedPharm Drug Inc.ANDACurrent
68071-2267CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2267CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2269CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2269CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68084-069CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-069CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-069CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-069CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-070CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-070CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-070CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-070CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-070CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-070CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-071CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-071CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-071CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-071CiprofloxacinCiprofloxacin HydrochlorideAmerican Health PackagingANDACurrent
68788-7857CiprofloxacinCiprofloxacinPreferred Pharmaceuticals IncANDACurrent
68788-8088CiprofloxacinCiprofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-8088CiprofloxacinCiprofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-9330CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
70934-623CiprofloxacinCiprofloxacinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1393CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
71335-1393CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
71335-1393CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8964ORIG2004-06-15