FDA.reportPublic FDA data

Application 212772

Type
ANDA
Sponsor
MSN LABS PVT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIRFENIDONEPIRFENIDONETABLET;ORAL267MGNoNo
002PIRFENIDONEPIRFENIDONETABLET;ORAL801MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69539-119PIRFENIDONEPIRFENIDONEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-120PIRFENIDONEPIRFENIDONEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
72205-181PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLCANDACurrent
72205-181PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLCANDACurrent
72205-181PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLCANDACurrent
72205-182PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLCANDACurrent
72205-182PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLCANDACurrent
72205-182PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64599ORIG2020-09-18