Drug Master Files for: CORTICOTROPIN
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CORTICOTROPIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11078 | A | II | 9/10/1994 | BACHEM AMERICAS INC | OVINE CORTICOTROPIN RELEASING FACTOR (0CRF) |
| 1780 | I | II | 8/21/1971 | FREDERIKSBERG CHEMICAL LABORATORIES LTD | CORTICOTROPIN (ACTH) |
| 21473 | A | II | 3/28/2008 | POLYPEPTIDE LABORATORIES INC | ALPHA-CORTICOTROPIN (1-24) ACETATE |
| 25341 | A | II | 9/28/2011 | MALLINCKRODT INC | H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION) |
| 278 | I | II | 10/28/1957 | ORTHANA KEMISK FABRIK A S | CORTICOTROPIN - GEL |
| 4181 | I | II | 6/10/1981 | MERCK SHARP AND DOHME BV | CORTICOTROPIN |
| 4384 | I | II | 12/17/1981 | SALK INSTITUTE | CORTICOTROPIN RELEASING FACTOR (CRF) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
