FDA.reportPublic FDA data

Application 202845

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFLUNISALDIFLUNISALTABLET;ORAL500MGNoNo
002DIFLUNISALDIFLUNISALTABLET;ORAL250MGNoNo
003DIFLUNISALDIFLUNISALTABLET;ORAL375MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14539-673diflunisaldiflunisalHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-673diflunisaldiflunisalHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-673diflunisaldiflunisalHeritage Pharma Labs, IncANDACurrent
14539-673diflunisaldiflunisalHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-673diflunisaldiflunisalHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-673diflunisaldiflunisalHeritage Pharmaceuticals Inc.ANDACurrent
50090-0450DIFLUNISALDIFLUNISALA-S Medication SolutionsANDACurrent
55700-559DIFLUNISALDIFLUNISALLake Erie Medical DBA Quality Care Products LLCANDACurrent
64980-181DIFLUNISALDIFLUNISALRising Pharmaceuticals Inc.ANDACurrent