Drug Master Files for: sufentanil citrate
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sufentanil citrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11327 | I | II | 2/6/1995 | JANSSEN PHARMACEUTICA NV | SUFENTANIL CITRATE |
| 12183 | A | II | 10/21/1996 | SPECGX LLC | SUFENTANIL BASE CODE 0310 |
| 14505 | A | II | 10/27/1999 | SPECGX LLC | SUFENTANIL CITRATE USP |
| 18420 | A | II | 6/9/2005 | JOHNSON MATTHEY PHARMACEUTICAL MATERIALS | SUFENTANIL BASE |
| 21821 | A | II | 7/23/2008 | CAMBREX CHARLES CITY INC | SUFENTANIL |
| 26800 | A | II | 12/13/2012 | CAMBREX CHARLES CITY INC | SUFENTANIL CITRATE |
| 30985 | A | II | 12/19/2016 | SPECGX LLC | SUFENTANIL CITRATE USP/EP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
