FDA.reportPublic FDA data

Application 075593

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 750MG BASENoNo
002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo
003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo
004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8147CiprofloxacinCiprofloxacinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8147CiprofloxacinCiprofloxacinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8147CiprofloxacinCiprofloxacinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6378CiprofloxacinciprofloxacinMajor PharmaceuticalsANDACurrent
0904-6378CiprofloxacinciprofloxacinMajor PharmaceuticalsANDACurrent
0904-6378CiprofloxacinciprofloxacinMajor PharmaceuticalsANDACurrent
0904-6378CiprofloxacinciprofloxacinMajor PharmaceuticalsANDACurrent
10544-036CiprofloxacinCiprofloxacinBlenheim Pharmacal, Inc.ANDACurrent
10544-604CIPROFLOXACINCiprofloxacinBlenheim Pharmacal, Inc.ANDACurrent
10544-607CIPROFLOXACINCiprofloxacinBlenheim Pharmacal, Inc.ANDACurrent
35356-733CiprofloxacinCiprofloxacinQuality Care Products, LLCANDACurrent
35356-733CiprofloxacinCiprofloxacinQuality Care Products, LLCANDACurrent
35356-733CiprofloxacinCiprofloxacinQuality Care Products, LLCANDACurrent
35356-733CiprofloxacinCiprofloxacinQuality Care Products, LLCANDACurrent
35356-928CiprofloxacinCiprofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-146CiprofloxacinCiprofloxacinQPharma IncANDACurrent
42852-001Ciprofloxacin HydrochlorideCiprofloxacin HydrochlorideApothecary Shop Wholesale Inc.ANDACurrent
43063-427CiprofloxacinCiprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-427CiprofloxacinCiprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-427CiprofloxacinCiprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-427CiprofloxacinCiprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
49349-612Ciprofloxacin HydrochlorideCiprofloxacin HydrochlorideREMEDYREPACK INC.ANDACurrent
49349-612Ciprofloxacin HydrochlorideCiprofloxacin HydrochlorideREMEDYREPACK INC.ANDACurrent
50090-3573CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-3573CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-5621CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-5624CiprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
53002-2642CiprofloxacinCiprofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2791CiprofloxacinCiprofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
55111-125CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-125CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-125CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-125CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-126CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-126CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-126CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-126CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-127CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-127CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-127CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-127CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-128CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-128CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-128CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-128CiprofloxacinCiprofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55154-7283CiprofloxacinciprofloxacinCardinal HealthANDACurrent
55154-7283CiprofloxacinciprofloxacinCardinal HealthANDACurrent
55154-7283CiprofloxacinciprofloxacinCardinal HealthANDACurrent
55154-7283CiprofloxacinciprofloxacinCardinal Health 107, LLCANDACurrent
55154-7283CiprofloxacinciprofloxacinCardinal HealthANDACurrent
58118-0127CiprofloxacinCiprofloxacinClinical Solutions WholesaleANDACurrent
58118-0127CiprofloxacinCiprofloxacinClinical Solutions WholesaleANDACurrent
58118-0127CiprofloxacinCiprofloxacinClinical Solutions WholesaleANDACurrent
63629-1326CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-1326CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-1326CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-1724CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-1724CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-1724CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-6358CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-6358CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-6360CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-6360CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-6360CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
63629-6360CiprofloxacinCiprofloxacinBryant Ranch PrepackANDACurrent
67296-0237CiprofloxacinCiprofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0237CiprofloxacinCiprofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0237CiprofloxacinCiprofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0599CIPROFLOXACINCiprofloxacinRedPharm Drug Inc.ANDACurrent
68071-2335CiprofloxacinCiprofloxacinNuCare Pharnaceuticals,Inc.ANDACurrent
68071-2374CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2391CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4387CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4387CiprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9006CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9006CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9006CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9006CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9006CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9024CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8731ORIG2004-06-15