FDA.reportPublic FDA data

Application 078895

Type
ANDA
Sponsor
UNICHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDETABLET;ORAL0.1MGNoNo
002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDETABLET;ORAL0.2MGNoNo
003CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDETABLET;ORAL0.3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7947clonidine hydrochlorideclonidine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7948clonidine hydrochlorideclonidine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8164clonidine hydrochlorideclonidine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
29300-135clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-135clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-135clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-135clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-136clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-136clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-136clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-136clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-137clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-137clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-137clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-137clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-468clonidine hydrochlorideclonidine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
43063-817clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-817clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-817clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-817clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-817clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-817clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-817clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-924clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-924clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-924clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-924clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-924clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-924clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-925clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-925clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-925clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-925clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-925clonidine hydrochlorideclonidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-797clonidine hydrochlorideclonidine hydrochloridemedsource pharmaceuticalsANDACurrent
50090-1908clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1908clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1908clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1909clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1909clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1910clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1910clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1910clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5577clonidine hydrochlorideclonidine hydrochlorideA-S Medication SolutionsANDACurrent
51655-339clonidine hydrochlorideclonidine hydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-339clonidine hydrochlorideclonidine hydrochlorideNorthwind PharmaceuticalsANDACurrent
53217-215clonidine hydrochlorideclonidine hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
58118-0072clonidine hydrochlorideclonidine hydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0072clonidine hydrochlorideclonidine hydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0072clonidine hydrochlorideclonidine hydrochlorideClinical Solutions Wholesale, LLCANDACurrent
60760-178clonidine hydrochlorideclonidine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-267CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-267CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-267CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-268CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-268CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-268CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-718CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-718CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
61919-718CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRXANDACurrent
63187-419clonidine hydrochlorideclonidine hydrochlorideProficient Rx LPANDACurrent
63187-419clonidine hydrochlorideclonidine hydrochlorideProficient Rx LPANDACurrent
63187-419clonidine hydrochlorideclonidine hydrochlorideProficient Rx LPANDACurrent
63629-7652clonidine hydrochlorideclonidine hydrochlorideBryant Ranch PrepackANDACurrent
63629-7652clonidine hydrochlorideclonidine hydrochlorideBryant Ranch PrepackANDACurrent
66267-061clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-061clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-062clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-062clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-062clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-464clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-464clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-464clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1196clonidine hydrochlorideclonidine hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1196clonidine hydrochlorideclonidine hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1196clonidine hydrochlorideclonidine hydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-4094clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4094clonidine hydrochlorideclonidine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7380clonidine hydrochlorideclonidine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7380clonidine hydrochlorideclonidine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent