Drug Master Files for: Mallinckrodt
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Mallinckrodt Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10543 | I | II | 10/26/1993 | MALLINCKRODT CHEMICAL INC | BRAIN NATRIURETIC PEPTIDE |
11227 | I | II | 12/1/1994 | MALLINCKRODT CHEMICAL INC | SODIUM HYDROGEN L-TARTRATE |
1133 | I | II | 1/24/1968 | MALLINCKRODT INC | DIATRIZOIC ACID |
11529 | I | II | 7/6/1995 | MALLINCKRODT INC | MORPHINE SULFATE INJECTION USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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