Drug Master Files for: METHOTREXATE SODIUM
✉ Email this page to a colleague
METHOTREXATE SODIUM Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1057 | I | II | 5/2/1967 | LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO | DICHLOROMETHOTREXATE |
10863 | I | II | 4/5/1994 | HEINRICH MACK NACHFOLGER | DISODIUM METHOTREXATE |
11704 | A | II | 10/5/1995 | EXCELLA GMBH AND CO KG | METHOTREXATE |
12472 | A | II | 4/11/1997 | EXCELLA GMBH AND CO KG | METHOTREXATE SODIUM |
12833 | I | II | 1/30/1998 | LIANYUNGANG PHARMACEUTICAL FACTORY | METHOTREXATE USP, NON-STERILE BULK DRUG |
20255 | A | II | 1/8/2007 | HUZHOU ZHANWANG PHARMACEUTICAL CO LTD | METHOTREXATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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