FDA.reportPublic FDA data

Application 076639

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7243ciprofloxacinciprofloxacinMajor PharmaceuticalsANDACurrent
10544-079ciprofloxacinciprofloxacinBlenheim Pharmacal, Inc.ANDACurrent
10544-603CiprofloxacinCiprofloxacinBlenheim Pharmacal, Inc.ANDACurrent
10544-608CiprofloxacinCiprofloxacinBlenheim Pharmacal, Inc.ANDACurrent
16571-411ciprofloxacinciprofloxacinRising Pharmaceuticals, IANDACurrent
16571-411ciprofloxacinciprofloxacinRising Pharma Holdings, Inc.ANDACurrent
16571-411ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-411ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-411ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-412ciprofloxacinciprofloxacinRising Pharmaceuticals, IANDACurrent
16571-412ciprofloxacinciprofloxacinRising Pharma Holdings, Inc.ANDACurrent
16571-412ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-412ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-412ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-413ciprofloxacinciprofloxacinRising Pharmaceuticals, IANDACurrent
16571-413ciprofloxacinciprofloxacinRising Pharma Holdings, Inc.ANDACurrent
16571-413ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-413ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
16571-413ciprofloxacinciprofloxacinRising Pharmaceuticals, Inc.ANDACurrent
24658-185CiprofloxacinCiprofloxacinPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-185CiprofloxacinCiprofloxacinPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
33261-164ciprofloxacinciprofloxacinAidarex Pharmaceuticals LLCANDACurrent
33261-367ciprofloxacinciprofloxacinAidarex Pharmaceuticals LLCANDACurrent
33261-399ciprofloxacinciprofloxacinAidarex Pharmaceuticals LLCANDACurrent
35356-846ciprofloxacinciprofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-846ciprofloxacinciprofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-846ciprofloxacinciprofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-846ciprofloxacinciprofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-410ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-767ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-767ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-767ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-767ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-767ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-767ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-869ciprofloxacinciprofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-471ciprofloxacinciprofloxacinMedsource PharmaceuticalsANDACurrent
45865-471ciprofloxacinciprofloxacinMedsource PharmaceuticalsANDACurrent
45865-530ciprofloxacinciprofloxacinMedsource PharmaceuticalsANDACurrent
50090-1648ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50090-1648ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50090-1648ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50090-1649ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50090-1649ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50090-2265ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50090-3160ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50090-3160ciprofloxacinciprofloxacinA-S Medication SolutionsANDACurrent
50436-0412ciprofloxacinciprofloxacinUnit Dose ServicesANDACurrent
50436-3135ciprofloxacinciprofloxacinUnit Dose ServicesANDACurrent
51655-118ciprofloxacinciprofloxacinNorthwind PharmaceuticalsANDACurrent
52959-734CIPROFLOXACINCIPROFLOXACIN HYDROCHLORIDEH. J. Harkins Company Inc.ANDACurrent
53002-2640ciprofloxacinciprofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2640ciprofloxacinciprofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2790ciprofloxacinciprofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2790ciprofloxacinciprofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53808-1073ciprofloxacinciprofloxacinState of Florida DOH Central PharmacyANDACurrent
54348-662ciprofloxacinCIPROFLOXACINPharmPak, Inc.ANDACurrent
54348-662ciprofloxacinCIPROFLOXACINPharmPak, Inc.ANDACurrent
54348-663ciprofloxacinCIPROFLOXACINPharmPak, Inc.ANDACurrent
54348-663ciprofloxacinCIPROFLOXACINPharmPak, Inc.ANDACurrent
55700-279ciprofloxacinciprofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-279ciprofloxacinciprofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-528ciprofloxacinciprofloxacinAmerican Health PackagingANDACurrent
60687-528CiprofloxacinCiprofloxacinAmerican Health PackagingANDACurrent
60687-528CiprofloxacinCiprofloxacinAmerican Health PackagingANDACurrent
60687-539ciprofloxacinciprofloxacinAmerican Health PackagingANDACurrent