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FDA Product

Metoprolol Succinate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Metoprolol Succinate

68258-6019

Regulatory Information

68258-6019

ANDA076862

C73584

February 17, 2012

USA

These highlights do not include all the information needed to use metoprolol succinate extended-release tablets USP safely and effectively. See full prescribing information for metoprolol succinate extended release tablets USP. Metoprolol succinate extended-release tablets USP Initial U.S. Approval: 1992

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

066070785

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

METOPROLOL SUCCINATE

Quantity: 50 mg in 1 1

Code: TH25PD4CCB

Class Code: ACTIR

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

POLOXAMER 188

Code: LQA7B6G8JG

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

Active Moieties

METOPROLOL

Code: GEB06NHM23

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