Application 211290

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE DINITRATEISOSORBIDE DINITRATETABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-556Isosorbide DinitrateIsosorbide DinitratePar Pharmaceutical, Inc.ANDACurrent
49884-556Isosorbide DinitrateIsosorbide DinitratePar Pharmaceutical, Inc.ANDACurrent
63629-9593Isosorbide DinitrateIsosorbide DinitrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69686ORIG2021-12-20