Drug Master Files for: linaclotide
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linaclotide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 24992 | A | II | 5/27/2011 | CORDEN PHARMA COLORADO INC | LINACLOTIDE |
| 25021 | A | II | 6/1/2011 | POLYPEPTIDE LABORATORIES SWEDEN AB | LINACLOTIDE DRUG SUBSTANCE |
| 25025 | A | II | 6/7/2011 | POLYPEPTIDE LABORATORIES INC | LINACLOTIDE DRUG SUBSTANCE |
| 28273 | A | II | 5/5/2014 | BACHEM AMERICAS INC | LINACLOTIDE (BULK) |
| 29708 | A | II | 9/22/2015 | AURO PEPTIDES LTD | LINACLOTIDE |
| 30266 | A | II | 11/16/2016 | SUN PHARMACEUTICAL INDUSTRIES LTD | LINACLOTIDE |
| 30274 | A | II | 3/10/2016 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LINACLOTIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
