Drug Master Files for: pralidoxime chloride
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pralidoxime chloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14208 | A | II | 6/14/1999 | AMRI RENSSELAER INC | PRALIDOXIME CHLORIDE USP |
| 21307 | A | II | 2/4/2008 | DISHMAN CARBOGEN AMCIS LTD | PRALIDOXIME CHLORIDE |
| 7065 | I | II | 7/13/1987 | PHARM ECO LABORATORIES INC | PRALIDOXIME CHLORIDE USP |
| 8750 | I | II | 9/17/1990 | DUPHAR MEDICAL DEVICES | ATROPINE/PRALIDOXIME CHLORIDE INJECTION (PERFORATED NEEDLE) |
| 8751 | I | II | 9/17/1990 | DUPHAR MEDICAL DEVICES | ATROPINE/PRALIDOXIME CHLORIDE INJECTION (RETRACTION NEEDLE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
