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FDA ANDA · ANDA076033

METFORMIN HYDROCHLORIDE

Sponsor: SENORES PHARMS

APPLICATION
ANDA076033
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-24
LATEST ACTION
2019-02-02
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

2019-02-02Labeling · Supplement 16 · standardAP
2019-02-02Labeling · Supplement 20 · standardAP
2002-12-10Manufacturing (CMC) · Supplement 5AP
2002-10-11Manufacturing (CMC) · Supplement 3AP
2002-09-26Manufacturing (CMC) · Supplement 2AP
2002-08-29Labeling · Supplement 4AP
2002-04-11Labeling · Supplement 1AP
2002-01-24OriginalAP
VIEW ON DRUGS@FDA ↗

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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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