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FDA ANDA · ANDA215255
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Sponsor: MACLEODS PHARMACEUTICALS LTD
APPLICATION
ANDA215255
TYPE
ANDA
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE 150MG, CANAGLIFLOZIN · TABLET, EXTENDED RELEASE
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE 1000MG, CANAGLIFLOZIN · TABLET, EXTENDED RELEASE
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE 500MG, CANAGLIFLOZIN · TABLET, EXTENDED RELEASE
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE 50MG, CANAGLIFLOZIN · TABLET, EXTENDED RELEASE
Approval history
2025-10-01UNKNOWN · 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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