Drug Master Files for: Dow Pharm
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Dow Pharm Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1256 | I | II | 12/5/1968 | MERRELL DOW RESEARCH INSTITUTE DIV MERRELL DOW PHARMACEUTICAL INC | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. |
26891 | A | II | 4/17/2013 | SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | ENOXAPARIN SODIUM USP |
32744 | A | II | 7/2/2018 | SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | ENOXAPARIN SODIUM USP |
604 | I | 7/5/1963 | MERRELL DOW PHARMS INC SUB MARION MERRELL DOW INC | MFG & PROCESS DATA; MONITORS RESPONS. FOR CLIN. & PHARMACOLOG. DATA | |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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