FDA Approval Activities for this Drug…

Sandostatin (octreotide acetate for injectable suspension) Depot 10, 20 and 30 mg. Novartis . NDA 21-008 11/25/98 11/30 12/1 7/4/99 Sandostatin Indication: Reduction of growth hormone and IGF-1 in acromegaly, the suppression of severe diarrhea and flushing associated with malignant carcinoid syndrome and for the treatment of the profuse watery diarrhea associated with VIPoma (vasoactive intestinal peptide tumor). Sandostatin (octreotide acetate) Injection, Novartis 19-667/S44 1/17/03 1/23/03 1/23/03 Sandostatin (octreotide acetate) Injection, Novartis 19-667/S42 2/10/03 2/12/03 Sandostatin (octreotide acetate) Injection, Novartis 19-667/S28 & S32 Sandostatin LAR Depot (octreotide acetate) Injection, Novartis Pharmaceuticals Sandostatin LAR Depot (octreotide acetate) Injection, Novartis Pharmaceuticals | Sandostatin LAR Depot (octreotide acetate) Injection, Novartis Pharma, Labeling Revision | Octreotide Acetate Injection, Bedford Labs, Approval | Octreotide Acetate Injection, Sicor Pharma, Tentative Approval | Octreotide Acetate Injection, Sicor Pharma, Tentative Approval | Octreotide Acetate Injection, Bedford Labs, Approval | Octreotide Acetate Injection, Bedford Labs, Approval

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