Application Nr Approved Date Route Status External Links
ANDA078088 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Alprazolam Orally Disintegrating Tablets, Usp Is A Benzodiazepine Indicated For: The Treatment Of Generalized Anxiety Disorder. ( 1.1 ) The Efficacy Of Alprazolam Was Demonstrated In 5 Short-Term, Placebo-Controlled Trials. ( 14 ) The Treatment Of Panic Disorder, With Or Without Agoraphobia. ( 1.2 ) The Efficacy Of Alprazolam In The Treatment Of Panic Disorder Was Established In 2 Short-Term, Placebo-Controlled Trials. ( 14 ) 1.1 Generalized Anxiety Disorders Alprazolam Orally Disintegrating Tablets, Usp Is Indicated For The Treatment Of Generalized Anxiety Disorder. The Efficacy Of Alprazolam In The Treatment Of Generalized Anxiety Disorder Was Demonstrated In 5 Short-Term, Placebo-Controlled Trials. [See Clinical Studies ( 14.1 )] 1.2 Panic Disorder Alprazolam Is Also Indicated For The Treatment Of Panic Disorder, With Or Without Agoraphobia. The Efficacy Of Alprazolam In The Treatment Of Panic Disorder Was Established In 2 Short-Term, Placebo-Controlled Trials. [See Clinical Studies ( 14.2 )]. Demonstrations Of The Effectiveness Of Alprazolam By Systematic Clinical Study Are Limited To 4 Months In Duration For Generalized Anxiety Disorder And 4 To 10 Weeks Duration For Panic Disorder; However, Patients With Panic Disorder Have Been Treated On An Open Basis For Up To 8 Months Without Apparent Loss Of Benefit. The Physician 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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