Drug Master Files for: ketoprofen
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ketoprofen Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10045 | I | II | 1/13/1993 | NORDIC SYNTHESIS AB | KETOPROFEN |
11099 | I | II | 9/28/1994 | SEPRACOR INC | (S)-KETOPROFEN |
11486 | I | II | 5/12/1995 | NAGASE FINE CHEMICALS LTD | S-KETOPROFEN |
12020 | I | II | 6/25/1996 | CHIREX LTD | KETOPROFEN |
18148 | I | II | 2/21/2005 | BIDACHEM SPA | KETOPROFEN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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