Drug Master Files for: Ohm
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Ohm Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1 | I | III | 11/4/1947 | ROHM AND HAAS CO | LETHANE 384 SPECIAL |
| 10625 | I | I | 12/15/1993 | LTS LOHMANN THERAPIE SYSTEME GMBH | MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN ANDERNACH, GERMANY |
| 10851 | I | I | 3/29/1994 | MERCK AND CO INC DIV MERCK SHARP AND DOHME | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOLLATE (MILAN) ITALY. |
| 11 | I | II | 3/12/1944 | ROHM AND HAAS CO | HYAMINE X (QUATERNARY AMMONIUM CHLORIDE COMPOUND) |
| 1140 | I | V | 2/1/1968 | MERCK SHARP AND DOHME RESEARCH LABORATORIES DIV MERCK AND CO INC | QUALIFICATIONS OF RESEARCH PERSONNEL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
