Application 210542

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANAGLIFLOZIN; METFORMIN HYDROCHLORIDECANAGLIFLOZIN;METFORMIN HYDROCHLORIDETABLET;ORAL50MG;500MGNoNo
002CANAGLIFLOZIN; METFORMIN HYDROCHLORIDECANAGLIFLOZIN;METFORMIN HYDROCHLORIDETABLET;ORAL50MG;1000MGNoNo
003CANAGLIFLOZIN; METFORMIN HYDROCHLORIDECANAGLIFLOZIN;METFORMIN HYDROCHLORIDETABLET;ORAL150MG;500MGNoNo
004CANAGLIFLOZIN; METFORMIN HYDROCHLORIDECANAGLIFLOZIN;METFORMIN HYDROCHLORIDETABLET;ORAL150MG;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
73768ORIG 2023-03-15