FDA.reportPublic FDA data

Application 203245

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 2.5MG BASENoNo
002AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 5MG BASENoNo
003AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0210Amlodipine BesylateAmlodipine BesylateKAISER FOUNDATION HOSPITALSANDACurrent
0179-0211Amlodipine BesylateAmlodipine BesylateKAISER FOUNDATION HOSPITALSANDACurrent
0179-0213Amlodipine BesylateAmlodipine BesylateKAISER FOUNDATION HOSPITALSANDACurrent
0615-8199Amlodipine BesylateAmlodipine BesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8200Amlodipine BesylateAmlodipine BesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8201Amlodipine BesylateAmlodipine BesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-562Amlodipine BesylateAmlodipine BesylateApotheca Inc.ANDACurrent
12634-599Amlodipine BesylateAmlodipine BesylateApotheca Inc.ANDACurrent
29300-241Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-241Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-241Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-241Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-242Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-242Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-242Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-242Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-243Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-243Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-243Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-243Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-396Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-396Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-396Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-396Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-397Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-397Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-397Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-397Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-398Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-398Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-398Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-398Amlodipine BesylateAmlodipine BesylateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
45865-617Amlodipine BesylateAmlodipine BesylateMedsource PharmaceuticalsANDACurrent
50090-1404Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1404Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1404Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1404Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1527Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1527Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1527Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1529Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1529Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-1529Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-4903Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
51655-052Amlodipine BesylateAmlodipine BesylateNorthwind PharmaceuticalsANDACurrent
51655-052Amlodipine BesylateAmlodipine BesylateNorthwind PharmaceuticalsANDACurrent
53002-2249Amlodipine BesylateAmlodipine BesylateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2249Amlodipine BesylateAmlodipine BesylateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2351Amlodipine BesylateAmlodipine BesylateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2351Amlodipine BesylateAmlodipine BesylateRPK Pharmaceuticals, Inc.ANDACurrent
53002-3249Amlodipine BesylateAmlodipine BesylateRPK Pharmaceuticals, Inc.ANDACurrent
60760-445Amlodipine BesylateAmlodipine BesylateSt. Mary's Medical Park PharmacyANDACurrent
60760-459Amlodipine BesylateAmlodipine BesylateSt. Mary's Medical Park PharmacyANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDirect_RxANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDirect_RxANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-782AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXANDACurrent
61919-844AMLODIPINE BESYLATEAMLODIPINE BESYLATEDirectRXANDACurrent
61919-844AMLODIPINE BESYLATEAMLODIPINE BESYLATEDirect_RxANDACurrent
61919-844AMLODIPINE BESYLATEAMLODIPINE BESYLATEDirectRXANDACurrent
63187-326Amlodipine BesylateAmlodipine BesylateProficient Rx LPANDACurrent
63187-326Amlodipine BesylateAmlodipine BesylateProficient Rx LPANDACurrent
63187-508Amlodipine BesylateAmlodipine BesylateProficient Rx LPANDACurrent
63187-508Amlodipine BesylateAmlodipine BesylateProficient Rx LPANDACurrent
63187-508Amlodipine BesylateAmlodipine BesylateProficient Rx LPANDACurrent
63629-8023Amlodipine BesylateAmlodipine BesylateBryant Ranch PrepackANDACurrent
63629-8023Amlodipine BesylateAmlodipine BesylateBryant Ranch PrepackANDACurrent
63629-8023Amlodipine BesylateAmlodipine BesylateBryant Ranch PrepackANDACurrent
63629-8024Amlodipine BesylateAmlodipine BesylateBryant Ranch PrepackANDACurrent
63629-8024Amlodipine BesylateAmlodipine BesylateBryant Ranch PrepackANDACurrent
67296-1529Amlodipine BesylateAmlodipine BesylateRedPharm Drug, Inc.ANDACurrent
67296-1529Amlodipine BesylateAmlodipine BesylateRedPharm Drug, Inc.ANDACurrent
67296-1529Amlodipine BesylateAmlodipine BesylateRedPharm Drug, Inc.ANDACurrent