FDA.reportPublic FDA data

Application 078459

Type
ANDA
Sponsor
IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL25MGNoNo
002METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL50MGNoNo
003METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-3155Metoprolol TartrateMetoprolol TartrateUnit Dose ServicesANDACurrent
50436-6578Metoprolol TartrateMetoprolol TartrateUnit Dose ServicesANDACurrent
53808-1018Metoprolol TartrateMetoprolol TartrateState of Florida DOH Central PharmacyANDACurrent
63304-579Metoprolol TartrateMetoprolol TartrateRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-580Metoprolol TartrateMetoprolol TartrateRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-581Metoprolol TartrateMetoprolol TartrateRanbaxy Pharmaceuticals Inc.ANDACurrent
63629-1462Metoprolol TartrateMetoprolol TartrateBryant Ranch PrepackANDACurrent
64725-0579Metoprolol TartrateMetoprolol TartrateTYA PharmaceuticalsANDACurrent
67046-473Metoprolol tartratemetoprolol tartrateContract Pharmacy Services-PAANDACurrent
67046-474Metoprolol TartrateMetoprolol tartrateContract Pharmacy Services-PAANDACurrent
68788-9686Metoprolol TartrateMetoprolol TartratePreferred Pharmaceuticals, Inc.ANDACurrent