Drug Master Files for: Mallinckrodt Inc
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Mallinckrodt Inc Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1133 | I | II | 1/24/1968 | MALLINCKRODT INC | DIATRIZOIC ACID |
| 11529 | I | II | 7/6/1995 | MALLINCKRODT INC | MORPHINE SULFATE INJECTION USP |
| 11636 | I | II | 8/30/1995 | MALLINCKRODT INC | MEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML |
| 12773 | I | II | 12/5/1997 | MALLINCKRODT INC | CT50034 |
| 12871 | I | II | 2/20/1998 | MALLINCKRODT INC | PENTAZOCINE HYDROCHLORIDE USP |
| 12913 | I | II | 3/10/1998 | MALLINCKRODT INC | OPTISON |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
