Application Nr Approved Date Route Status External Links
ANDA090615 2010-07-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Metoprolol Succinate, Is A Beta1-Selective Adrenoceptor Blocking Agent. Metoprolol Succinate Extended-Release Tablets Are Indicated For The Treatment Of: •hypertension (1.1) •angina Pectoris (1.2) •heart Failure - For The Treatment Of Stable, Symptomatic (nyha Class Ii Or Iii) Heart Failure Of Ischemic, Hypertensive, Or Cardiomyopathic Origin.(1.3) 1.1 Hypertension Metoprolol Succinate Extended-Release Tablets Are Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Agents [see Dosage And Administration (2)]. 1.2 Angina Pectoris Metoprolol Succinate Extended-Release Tablets Are Indicated In The Long-Term Treatment Of Angina Pectoris, To Reduce Angina Attacks And To Improve Exercise Tolerance. 1.3 Heart Failure Metoprolol Succinate Extended-Release Tablets Are Indicated For The Treatment Of Stable, Symptomatic (nyha Class Ii Or Iii) Heart Failure Of Ischemic, Hypertensive, Or Cardiomyopathic Origin. It Was Studied In Patients Already Receiving Ace Inhibitors, Diuretics, And, In The Majority Of Cases, Digitalis. In This Population, Metoprolol Succinate Extended-Release Tablets Decreased The Rate Of Mortality Plus Hospitalization, Largely Through A Reduction In Cardiovascular Mortality And Hospitalizations For Heart Failure.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Hypromelloses HYPROMELLOSES Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metoprolol Succinate METOPROLOL SUCCINATE ZINC1530717

Comments