APPLICATION
ANDA213654
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 12.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 25MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 10MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-01-06UNKNOWN · Original · standardTA
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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