Application 212243

Type
ANDA
Sponsor
CIPLA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDEEMPAGLIFLOZIN;METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1000MGNoNo

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
81187ORIG 2025-02-10
81186ORIG 2025-02-10