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FDA ANDA · ANDA213320

METFORMIN HYDROCHLORIDE

Sponsor: HARMAN FINOCHEM

APPLICATION
ANDA213320
TYPE
ANDA
ORIGINAL APPROVAL
2021-12-03
LATEST ACTION
2023-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL

Approval history

2023-05-26Manufacturing (CMC) · Supplement 2 · unknownAP
2021-12-03UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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