FDA.reportPublic FDA data

Application 008578

Type
NDA
Sponsor
VYERA PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DARAPRIMPYRIMETHAMINETABLET;ORAL25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69413-330DaraprimpyrimethamineVyera Pharmaceuticals LLCNDACurrent
69413-330DaraprimpyrimethamineVyera Pharmaceuticals LLCNDACurrent
69413-330DaraprimpyrimethamineVyera Pharmaceuticals LLCNDACurrent
72647-330PyrimethaminepyrimethamineOAKRUM PHARMA, LLCNDA AUTHORIZED GENERICCurrent
72647-330PyrimethaminepyrimethamineOAKRUM PHARMA, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48807SUPPL2017-06-22
48806ORIG2017-06-22
47592SUPPL2017-03-20
47580SUPPL2017-03-17
153SUPPL2004-06-02
10704SUPPL2003-12-01
102SUPPL2003-11-25
32966SUPPL2002-10-10