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Last Updated: March 19, 2024

Drug Master Files for: OCTREOTIDE ACETATE


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OCTREOTIDE ACETATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14994 A II 8/4/2000 POLYPEPTIDE LABORATORIES INC OCTREOTIDE ACETATE DRUG SUBSTANCE
16760 A II 8/13/2003 BACHEM AMERICAS INC OCTREOTIDE ACETATE USP
17678 A II 9/15/2004 SUN PHARMACEUTICAL INDUSTRIES LTD OCTREOTIDE ACETATE (PROCESS I)
17777 A II 10/21/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD OCTREOTIDE ACETATE
18740 A II 9/8/2005 BCN PEPTIDES SA OCTREOTIDE ACETATE
19567 A II 6/28/2006 CHEMI SPA OCTREOTIDE ACETATE
21704 I II 6/13/2008 POLYPEPTIDE LABORATORIES INC OCTREOTIDE ACETATE BY GRANULATION
>DMF No. >Status >Type >Submission Date >Holder >Subject

Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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