Drug Master Files for: tinidazole
✉ Email this page to a colleague
tinidazole Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10350 | I | II | 6/23/1993 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | TINIDAZOLE |
1704 | I | II | 4/20/1971 | PFIZER INC | TINIDAZOLE BULK |
18824 | A | II | 9/26/2005 | ZHEJIANG SUPOR PHARMACEUTICALS CO LTD | TINIDAZOLE (NON-STERILE DRUG SUBSTANCE) |
6226 | I | II | 9/6/1985 | PFIZER LABORATORIES DIV PFIZER INC | TINIDAZOLE |
6275 | I | II | 4/21/1986 | FARCHEMIA SRL | TINIDAZOLE USP XXI |
6544 | I | II | 8/19/1986 | PFIZER SA | TINIDAZOLE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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