Drug Master Files for: Lyphomed
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Lyphomed Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1767 | I | II | 6/28/1971 | LYPHOMED INC | MANUFACTURING FACILITIES AND OPERATIONAL CONTROLS |
4155 | I | II | 5/5/1981 | LYPHOMED INC | MANUF. PROCEDS FOR OXYTOCIN INJECT (BULK)--IN CHICAGO, ILL. FACILITIES |
4490 | I | II | 4/2/1982 | LYPHOMED INC | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ORLANDO, FLORIDA. |
5761 | I | II | 3/19/1985 | LYPHOMED INC | ISOSORBIDE DINITRATE INJECTION (50ML AND 100ML) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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