Drug Master Files for: GLUCAGON
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GLUCAGON Drug Master Files
| 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 |
| 26326 | A | II | 8/21/2012 | AMBIOPHARM INC | GLUCAGON, NON-STERILE, BULK DRUG SUBSTANCE |
| 2961 | I | II | 6/7/1977 | NOVO NORDISK AS | GLUCAGON (BULK) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
