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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 | Sandostatin (octreotide acetate) Injection, Novartis Pharma, Labeling Revision | Octreotide Acetate Injection, Sicor Pharma, Approval | Octreotide Acetate Injection, Sicor Pharma, Approval | Octreotide Acetate Injection, American Pharma, Approval | Octreotide Acetate Injection, American Pharma, Approval | Sandostatin (octreotide acetate for injectable suspension) LAR Depot, Novartis, Patient Population Altered & Labeling Revision | Octreotide Acetate Injection, Sun Pharma, Approval | Octreotide Acetate Injection, Sun Pharma, Approval | Sandostatin LAR Depot Injection (octreotide acetate), Novartis Pharma, New or Modified Indication | Sandostatin (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision | Sandostatin (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision | Sandostatin LAR (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision | Octreotide Acetate Injection, Bioniche Pharma, Approval | Octreotide Acetate (Preservative Free) Injection, Wockhardt, Ltd., Approval | Sandostatin LAR (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
  
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