FDA.reportPublic FDA data

Application 206392

Type
ANDA
Sponsor
AMNEAL PHARMS

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
42291-116Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAvKARE, Inc.ANDACurrent
42291-116Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAvKARE, Inc.ANDACurrent
42291-116Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAvKAREANDACurrent
42291-116Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAvKAREANDACurrent
60687-305Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAmerican Health PackagingANDACurrent
62559-850Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleANI Pharmaceuticals, Inc.ANDACurrent
62559-850Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleANI Pharmaceuticals, Inc.ANDACurrent
62559-850Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleANI Pharmaceuticals, Inc.ANDACurrent
65162-596Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAmneal Pharmaceuticals LLCANDACurrent
65162-596Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAmneal Pharmaceuticals LLCANDACurrent
65162-596Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAmneal Pharmaceuticals LLCANDACurrent
65162-596Aspirin and Extended-Release DipyridamoleAspirin and Extended-Release DipyridamoleAmneal Pharmaceuticals LLCANDACurrent