Drug Master Files for: calcitonin
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calcitonin Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12775 | I | II | 12/2/1997 | POLYPEPTIDE LABORATORIES AS | CALCITONIN (SALMON), PH.EUR. |
1422 | I | 9/4/1969 | ARMOUR PHARMACEUTICAL CO | SALMON CALCITONIN | |
14426 | A | II | 9/30/1999 | UGP THERAPEUTICS INC | CALCITONIN-SALMON (RDNA ORIGIN) |
15684 | A | II | 10/19/2001 | POLYPEPTIDE LABORATORIES SWEDEN AB | CALCITONIN (SALMON) |
19579 | A | II | 7/5/2006 | BCN PEPTIDES SA | SALMON CALCITONIN |
2449 | I | 5/6/1975 | ARMOUR PHARMACEUTICAL CO | CALCITONIN-SALMON SYNTHETIC | |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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