FDA.reportPublic FDA data

Application 215586

Type
ANDA
Sponsor
RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATETABLET;ORAL37.5MG;20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-246Isosorbide dinitrate and hydralazine hydrochlorideIsosorbide dinitrate and hydralazine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-246Isosorbide dinitrate and hydralazine hydrochlorideIsosorbide dinitrate and hydralazine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71925ORIG2022-08-26