Alprazolam ODT C-IV
Alprazolam ODT C-IV is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Alprazolam ODT C-IV. Available dosage form: tablet, orally disintegrating.
Drug Details
- Generic Name
- Alprazolam ODT C-IV
- Brand Names
- Alprazolam ODT C-IV
- Application Number
- ANDA078088
- Sponsor
- Direct_Rx
- NDC Codes
- 1
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
- Routes
- ORAL
- Active Ingredients
- ALPRAZOLAM
Indications and Usage
1.1 Generalized Anxiety Disorder Alprazolam orally disintegrating tablets, USP are 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 orally disintegrating tablets, USP are 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.