Application Nr Approved Date Route Status External Links
ANDA078703 2011-07-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hypertension Propranolol Hydrochloride Extended-Release Capsules, 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 Extended-Release Capsules, Usp, Are Not Indicated In The Management Of Hypertensive Emergencies. Angina Pectoris Due To Coronary Atherosclerosis Propranolol Hydrochloride Extended-Release Capsules, Usp, Are Indicated To Decrease Angina Frequency And Increase Exercise Tolerance In Patients With Angina Pectoris. Migraine Propranolol Hydrochloride Extended-Release Capsules, 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. Hypertrophic Subaortic Stenosis Propranolol Hydrochloride Extended-Release Capsules, Usp, Improve Nyha Functional Class In Symptomatic Patients With Hypertrophic Subaortic Stenosis.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. Hypromellose Phthalate HYPROMELLOSE PHTHALATE Unresolved
3. Povidones POVIDONES Unresolved
4. Diethyl Phthalate DIETHYL PHTHALATE Molecular
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
7. Ammonia AMMONIA Molecular
8. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

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

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