FDA.reportPublic FDA data

Application 210318

Type
ANDA
Sponsor
GLENMARK PHARMS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASPIRIN AND DIPYRIDAMOLEASPIRIN; DIPYRIDAMOLECAPSULE, EXTENDED RELEASE;ORAL25MG;200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-405ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-405ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-405ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-405ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEGlenmark Pharmaceuticals Inc., USAANDACurrent