Drug Master Files for: GLUCAGON

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GLUCAGON Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10613	I	II	12/10/1993	PENINSULA LABS INC	GLUCAGON-LIKE PEPTIDE 1 (7-36)
11110	I	II	9/30/1994	BACHEM INC	GLUCAGON-LIKE PEPTIDE (7-37)
12297	I	II	12/27/1996	BACHEM CALIFORNIA	GLUCAGON (1-29), HUMAN
13906	I	II	12/22/1998	RESTORAGEN INC	RECOMBINANT GLUCAGON-LIKE PEPTIDE-1 (RGLP)
18277	A	II	4/12/2005	BACHEM AG	GLUCAGON
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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