Application 212364

Type
ANDA
Sponsor
ANNORA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMPAGLIFLOZIN; LINAGLIPTINEMPAGLIFLOZIN;LINAGLIPTINUNKNOWNUNKNOWNNoNo
002EMPAGLIFLOZIN; LINAGLIPTINEMPAGLIFLOZIN;LINAGLIPTINTABLET;ORAL25MG; 5MGNoNo

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
67041ORIG2021-04-13