Application 214544

Type
NDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDEDOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDETABLET;ORAL50MG;200MG;25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73261ORIG2023-01-20