FDA.reportPublic FDA data

Application 091471

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFAVIRENZEFAVIRENZTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
70518-1013EfavirenzefavirenzREMEDYREPACK INC.ANDACurrent
70518-1013EfavirenzefavirenzREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39616ORIG2016-02-23
31532ORIG2016-02-19