Drug Master Files for: orphenadrine citrate
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orphenadrine citrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10217 | I | I | 4/27/1993 | DSM PHARMA CHEMICALS SOUTH HAVEN INC | 3M ORPHENADRINE CITRATE |
| 14971 | A | II | 7/19/2000 | PROCOS SPA | ORPHENADRINE CITRATE |
| 2942 | I | II | 5/9/1977 | PROCOS SPA | ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE |
| 4457 | I | II | 2/8/1982 | ORGAMOL SA | ORPHENADRINE CITRATE/ORPHENADRINE HCL (TRANSFER TO D 4811 1/13/88) |
| 4811 | I | II | 1/21/1983 | ORGAMOL SA | ORPHENADRINE CITRATE AND ORPHENADRINE HCL. |
| 5722 | A | II | 2/22/1985 | ALBEMARLE CORP | ORPHENADRINE CITRATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
