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FDA ANDA · ANDA203894

METOPROLOL SUCCINATE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA203894
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-23
LATEST ACTION
2023-09-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METOPROLOL SUCCINATEPrescription
METOPROLOL SUCCINATE EQ 100MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL
METOPROLOL SUCCINATEPrescription
METOPROLOL SUCCINATE EQ 25MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL
METOPROLOL SUCCINATEPrescription
METOPROLOL SUCCINATE EQ 200MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL
METOPROLOL SUCCINATEPrescription
METOPROLOL SUCCINATE EQ 50MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-09-21Labeling · Supplement 11 · standardAP
2023-05-05Labeling · Supplement 10 · standardAP
2023-05-05Labeling · Supplement 8 · standardAP
2018-10-29Manufacturing (CMC) · Supplement 3AP
2018-03-23UNKNOWN · OriginalAP
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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