Application Nr Approved Date Route Status External Links
ANDA090871 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Alprazolam Extended-Release Tablets Are Indicated For The Treatment Of Panic Disorder, With Or Without Agoraphobia. This Claim Is Supported On The Basis Of Two Positive Studies With Alprazolam Extended-Release Conducted In Patients Whose Diagnoses Corresponded Closely To The Dsm-Iii-R/iv Criteria For Panic Disorder (see Clinical Efficacy Trials ). Panic Disorder (dsm-Iv) Is Characterized By Recurrent Unexpected Panic Attacks, I.e., A Discrete Period Of Intense Fear Or Discomfort In Which Four (or More) Of The Following Symptoms Develop Abruptly And Reach A Peak Within 10 Minutes: (1) Palpitations, Pounding Heart, Or Accelerated Heart Rate; (2) Sweating; (3) Trembling Or Shaking; (4) Sensations Of Shortness Of Breath Or Smothering; (5) Feeling Of Choking; (6) Chest Pain Or Discomfort; (7) Nausea Or Abdominal Distress; (8) Feeling Dizzy, Unsteady, Lightheaded, Or Faint; (9) Derealization (feelings Of Unreality) Or Depersonalization (being Detached From Oneself); (10) Fear Of Losing Control; (11) Fear Of Dying; (12) Paresthesias (numbness Or Tingling Sensations); (13) Chills Or Hot Flushes. The Longer-Term Efficacy Of Alprazolam Extended-Release Has Not Been Systematically Evaluated. Thus, The Physician Who Elects To Use This Drug For Periods Longer Than 8 Weeks Should Periodically Reassess The Usefulness Of The Drug For The Individual Patient.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Alprazolam ALPRAZOLAM ZINC903

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