FDA.reportPublic FDA data

Application 208947

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASENoNo
002QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 150MG BASENoNo
003QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 200MG BASENoNo
004QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 300MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
34908-636Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
34908-637Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
34908-638Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
34908-639Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
51407-073Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-073Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-073Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-074Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-074Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-074Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-075Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-075Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-075Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-076Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-076Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-076Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-077Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-077Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-077Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
70518-2280Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2282Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2309Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2416Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent