Drug Master Files for: PROTAMINE SULFATE
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PROTAMINE SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1037 | I | II | 3/1/1967 | HOFFMANN LA ROCHE INC | PROTAMINE HCL, RO 6-1588/1 |
| 14973 | I | II | 7/27/2000 | BIOCHEM CORP | PROTAMINE SULFATE |
| 15421 | A | II | 1/25/2000 | YUKI GOSEI KOGYO CO LTD | PROTAMINE SULFATE |
| 19008 | I | II | 12/2/2005 | RELIABLE BIOPHARMACEUTICAL LLC | PROTAMINE SULFATE USP |
| 20538 | A | II | 5/11/2007 | ALPS PHARMACEUTICAL IND CO LTD | PROTAMINE SULFATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
