FDA.reportPublic FDA data

Application 205626

Type
NDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINELAMIVUDINE; NEVIRAPINE; ZIDOVUDINETABLET;ORAL150MG;200MG;300MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42571-166Lamivudine, Nevirapine, and ZidovudineLamivudine, Nevirapine, and ZidovudineMicro Labs LimitedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56557ORIG2018-11-26
55213ORIG2018-08-20
55179ORIG2018-08-15
55178ORIG2018-08-15
63009ORIG1900-01-01
63008ORIG1900-01-01
63007ORIG1900-01-01