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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212198
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET;ORAL Discontinued None No No
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET;ORAL Discontinued None No No
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;500MG TABLET;ORAL Discontinued None No No
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;1GM TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/07/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212198Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/13/2024 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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