The U.S. Food and Drug Administration granted approval for the original Abbreviated New Drug Application (ANDA) 078442 covering Alprazolam extended‑release tablets on October 15, 2007. A subsequent labeling supplement (submission number 2) received approval on November 29, 2011.
The approved products are oral, extended‑release tablets marketed under the brand name Alprazolam. Four product numbers were listed: 001 (0.5 mg), 002 (1 mg), 003 (2 mg), and 004 (3 mg). Each contains alprazolam as the sole active ingredient.
All four tablet strengths are currently marked as discontinued. The sponsor for the application is PH Health, and none of the products are designated as reference drugs or reference standards.
Regulatorische Updates9. Sept. 2026•3 Min. Lesezeit
FDA Approves ANDA078442 for Alprazolam Extended-Release Tablets (Discontinued)
The FDA approved the original ANDA for Alprazolam extended‑release tablets (product numbers 001‑004) on Oct 15 2007, with a labeling supplement approved on Nov 29 2011. All four strengths (0.5 mg, 1 mg, 2 mg, 3 mg) are now listed as discontinued by sponsor PH Health.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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