Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com