Drug Master Files for: FLURBIPROFEN SODIUM
FLURBIPROFEN SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10248 | I | II | 5/17/1993 | WYCKOFF CHEMICAL CO INC | FLURBIPROFEN SODIUM |
| 11902 | A | II | 3/26/1996 | ALBEMARLE CORP | FLURBIPROFEN USP & BP |
| 12752 | I | II | 11/17/1997 | DSM PHARMA CHEMICALS NORTH AMERICA INC | R-FLURBIPROFEN |
| 2435 | A | II | 3/13/1975 | AESICA PHARMACEUTICALS LTD | FLURBIPROFEN AND SODIUM FLUBIPROFEN |
| 29759 | A | II | 9/19/2015 | SUN PHARMACEUTICAL INDUSTRIES LTD | S-(+)-FLURBIPROFEN |
| 32876 | A | II | 10/25/2018 | VASUDHA PHARMA CHEM LTD | FLURBIPROFEN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
