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 |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
