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FDA ANDA · ANDA207678
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sponsor: DR REDDYS LABS SA
APPLICATION
ANDA207678
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-09
LATEST ACTION
2023-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE · TABLET, EXTENDED RELEASE · ORAL
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG, SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-08-09UNKNOWN · Original · standardAP
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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