FDA.reportPublic FDA data

Application 077443

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOLATENOLOLTABLET;ORAL25MGNoNo
002ATENOLOLATENOLOLTABLET;ORAL50MGNoNo
003ATENOLOLATENOLOLTABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8372AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8373AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-167AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
10544-586AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
16571-430AtenololAtenololPack Pharmaceuticals LLCANDACurrent
16571-431AtenololAtenololPack Pharmaceuticals LLCANDACurrent
16571-441AtenololAtenololPack Pharmaceuticals LLCANDACurrent
42708-143AtenololAtenololQPharma IncANDACurrent
50090-5266AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5266AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5367AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5367AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5408AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5408AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5408AtenololAtenololA-S Medication SolutionsANDACurrent
50436-0438AtenololAtenololUnit Dose ServicesANDACurrent
53002-2004AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-2138AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-4108AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
55700-661AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-661AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-661AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
60760-437AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-437AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-642AtenololAtenololSt Mary's Medical Park PharmacyANDACurrent
60760-642AtenololAtenololSt Mary's Medical Park PharmacyANDACurrent
60760-643AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-643AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
61919-854ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-854ATENOLOLATENOLOLDirect_RxANDACurrent
61919-854ATENOLOLATENOLOLDirect_RxANDACurrent
64980-437AtenololAtenololRising Pharmaceuticals, Inc.ANDACurrent
64980-438AtenololAtenololRising Pharmaceuticals, Inc.ANDACurrent
64980-439AtenololAtenololRising Pharmaceuticals, Inc.ANDACurrent
67296-1726AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1726AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1732AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1732AtenololAtenololRedPharm Drug, Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4553AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4553AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4751AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4751AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4751AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5162AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5162AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7616AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7616AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7616AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2866AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2866AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3007AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3007AtenololAtenololREMEDYREPACK INC.ANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent