Drug Master Files for: linaclotide

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linaclotide Drug Master Files

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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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