FDA.reportPublic FDA data

Application 202674

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 25MG BASENoNo
002QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 50MG BASENoNo
003QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 100MG BASENoNo
004QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 200MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 300MG BASENoNo
006QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-147Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-147Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-147Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-147Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-147Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-147Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-148Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-148Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-148Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-148Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-148Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-148Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-149Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-149Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-149Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-149Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-149Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-149Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-150Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-150Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-150Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-150Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-150Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-150Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-151Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-151Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-151Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-151Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-151Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-151Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-152Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-152Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-152Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-152Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-152Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-152Quetiapine FumarateQuetiapine FumarateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-3303Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3303Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3377Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3377Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3377Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3377Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3379Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3392Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3540Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3983Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3983Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-4022Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-4022Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-4022Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-4022Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
55700-833Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent
68788-7538Quetiapine FumarateQuetiapine FumaratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7538Quetiapine FumarateQuetiapine FumaratePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0638Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-0638Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-0723Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-0723Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-0989Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-0989Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-1018Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-1018Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-1018Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-1018Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-2175Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-2175Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
71335-1353Quetiapine FumarateQuetiapine FumarateBryant Ranch PrepackANDACurrent
71335-1353Quetiapine FumarateQuetiapine FumarateBryant Ranch PrepackANDACurrent
71335-1353Quetiapine FumarateQuetiapine FumarateBryant Ranch PrepackANDACurrent
71335-1353Quetiapine FumarateQuetiapine FumarateBryant Ranch PrepackANDACurrent
80425-0184Quetiapine FumarateQuetiapine FumarateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0184Quetiapine FumarateQuetiapine FumarateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent