FDA.reportPublic FDA data

Application 090617

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG TARTRATENoNo
002METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7823Metoprolol succinateMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7823Metoprolol succinateMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7824Metoprolol succinateMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7824Metoprolol succinateMetoprolol succinateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6322Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6322Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6322Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6322Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6322Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6323Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6323Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6323Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6323Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
0904-6323Metoprolol succinateMetoprolol succinateMajor PharmaceuticalsANDACurrent
33261-898Metoprolol succinateMetoprolol succinateAidarex Pharmaceuticals LLCANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-624Metoprolol succinateMetoprolol succinatePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-798Metoprolol succinateMetoprolol succinateMedsource PharmaceuticalsANDACurrent
45865-814Metoprolol succinateMetoprolol succinatemedsource pharmaceuticalsANDACurrent
50090-3896Metoprolol succinateMetoprolol succinateA-S Medication SolutionsANDACurrent
50268-540Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-540Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-540Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-540Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-540Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-541Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-541Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-541Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-541Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50268-541Metoprolol succinateMetoprolol succinateAvPAKANDACurrent
50436-7054Metoprolol succinateMetoprolol succinateUnit Dose ServicesANDACurrent
53002-1612Metoprolol succinateMetoprolol succinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-1781Metoprolol succinateMetoprolol succinateRPK Pharmaceuticals, Inc.ANDACurrent
55111-466Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55111-466Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55111-467Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55111-467Metoprolol succinateMetoprolol succinateDr. Reddy's Laboratories LimitedANDACurrent
55154-4698Metoprolol SuccinateMetoprolol SuccinateCardinal HealthANDACurrent
55154-4698Metoprolol SuccinateMetoprolol SuccinateCardinal Health 107, LLCANDACurrent
55154-4987Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-4993Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-6886Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-6886Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-6886Metoprolol succinateMetoprolol succinateCardinal Health 107, LLCANDACurrent
55154-7280Metoprolol succinateMetoprolol succinateCardinal Health 107, LLCANDACurrent
55154-7280Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55154-7280Metoprolol succinateMetoprolol succinateCardinal HealthANDACurrent
55700-192Metoprolol succinateMetoprolol succinateLake Erie Medical DBA QuaANDACurrent
55700-192Metoprolol succinateMetoprolol succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-192Metoprolol succinateMetoprolol succinateQuality Care Products LLCANDACurrent
55700-253Metoprolol succinateMetoprolol succinateQuality Care Products LLCANDACurrent
55700-253Metoprolol succinateMetoprolol succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-253Metoprolol succinateMetoprolol succinateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-390Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-390Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-390Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-390Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-402Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-402Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-402Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60687-402Metoprolol SuccinateMetoprolol SuccinateAmerican Health PackagingANDACurrent
60760-467Metoprolol succinateMetoprolol succinateSt. Mary's Medical Park PharmacyANDACurrent
61919-913METOPROLOL SUCCINATEMETOPROLOL SUCCINATEDirectRXANDACurrent
67296-1720Metoprolol succinateMetoprolol succinateRedPharm Drug, Inc.ANDACurrent
67296-1720Metoprolol succinateMetoprolol succinateRedPharm Drug, Inc.ANDACurrent
68001-121Metoprolol succinateMetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-121Metoprolol succinateMetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-122Metoprolol succinateMetoprolol succinateBluePoint LaboratoriesANDACurrent
68001-122Metoprolol succinateMetoprolol succinateBluePoint LaboratoriesANDACurrent
68071-1922Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1922Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1922Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2191Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2191Metoprolol succinateMetoprolol succinateNuCare Pharmaceuticals, Inc.ANDACurrent