FDA.reportPublic FDA data

Application 214196

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETRAVIRINEETRAVIRINETABLET;ORAL25MGNoNo
002ETRAVIRINEETRAVIRINETABLET;ORAL100MGNoNo
003ETRAVIRINEETRAVIRINETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-473etravirineetravirineAvKAREANDACurrent
42291-474etravirineetravirineAvKAREANDACurrent
60219-1720etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1720etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1721etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1721etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1722etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
60219-1722etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1720etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1721etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1722etravirineetravirineAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68030ORIG2021-07-08