Application Nr Approved Date Route Status External Links
ANDA071972 1988-04-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hypertension Propranolol Hydrochloride Tablets Usp Are Indicated In The Management Of Hypertension. They May Be Used Alone Or Used In Combination With Other Antihypertensive Agents, Particularly A Thiazide Diuretic. Propranolol Hydrochloride Tablets Usp Are Not Indicated In The Management Of Hypertensive Emergencies. Angina Pectoris Due To Coronary Atherosclerosis Propranolol Hydrochloride Tablets Usp Are Indicated To Decrease Angina Frequency And Increase Exercise Tolerance In Patients With Angina Pectoris. Atrial Fibrillation Propranolol Hydrochloride Tablets Usp Are Indicated To Control Ventricular Rate In Patients With Atrial Fibrillation And A Rapid Ventricular Response. Myocardial Infarction Propranolol Hydrochloride Tablets Usp Are Indicated To Reduce Cardiovascular Mortality In Patients Who Have Survived The Acute Phase Of Myocardial Infarction And Are Clinically Stable. Migraine Propranolol Hydrochloride Tablets Usp Are Indicated For The Prophylaxis Of Common Migraine Headache. The Efficacy Of Propranolol In The Treatment Of A Migraine Attack That Has Started Has Not Been Established, And Propranolol Is Not Indicated For Such Use. Essential Tremor Propranolol Hydrochloride Tablets Usp Are Indicated In The Management Of Familial Or Hereditary Essential Tremor. Familial Or Essential Tremor Consists Of Involuntary, Rhythmic, Oscillatory Movements, Usually Limited To The Upper Limbs. It Is Absent At Rest, But Occurs When The Limb Is Held In A Fixed Posture Or Position Against Gravity And During Active Movement. Propranolol Hydrochloride Causes A Reduction In The Tremor Amplitude, But Not In The Tremor Frequency. Propranolol Hydrochloride Tablets Usp Are Not Indicated For The Treatment Of Tremor Associated With Parkinsonism. Hypertrophic Subaortic Stenosis Propranolol Hydrochloride Tablets Usp Improves Nyha Functional Class In Symptomatic Patients With Hypertrophic Subaortic Stenosis. Pheochromocytoma Propranolol Hydrochloride Tablets Usp Are Indicated As An Adjunct To Alpha-Adrenergic Blockade To Control Blood Pressure And Reduce Symptoms Of Catecholamine-Secreting Tumors.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Propranolol Hydrochloride PROPRANOLOL HYDROCHLORIDE ZINC20240

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