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FDA ANDA · ANDA211143

METOPROLOL SUCCINATE

metoprolol succinate er tablets

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA211143
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-25
LATEST ACTION
2023-07-03
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

2023-07-03Labeling · Supplement 4 · standardAP
2022-11-08Labeling · Supplement 3 · standardAP
2022-08-16Labeling · Supplement 2 · standardAP
2020-11-25UNKNOWN · Original · standardAP
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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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