Drug Master Files for: sulindac
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sulindac Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12224 | A | II | 11/15/1996 | OLON SPA | SULINDAC |
| 13018 | I | II | 6/10/1998 | ZACH SYSTEM SPA | SULINDAC SULFONE |
| 13089 | I | II | 7/21/1998 | DIPHARMA SPA | SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY |
| 16180 | A | II | 10/8/2002 | DR REDDYS LABORATORIES LTD | SULINDAC USP |
| 20104 | I | II | 12/28/2006 | AGNO PHARMA USA | SULINDAC |
| 20742 | I | II | 7/30/2007 | FLAMMA SPA | SULINDAC |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
