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FDA ANDA · ANDA211309
METFORMIN HYDROCHLORIDE ORAL SOLUTION
metformin hydrochloride
Sponsor: SAPTALIS PHARMS
APPLICATION
ANDA211309
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-03
LATEST ACTION
2024-12-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG/5ML · SOLUTION · ORAL
Approval history
2024-12-11Labeling · Supplement 9 · standardAP
2020-03-03UNKNOWN · 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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