Drug Master Files for: MESALAMINE
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MESALAMINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11807 | A | II | 1/15/1996 | CORDEN PHARMA BERGAMO SPA | MESALAMINE |
| 11951 | A | II | 4/29/1996 | CHEMI SPA | MESALAMINE USP |
| 13883 | A | II | 12/3/1998 | ERREGIERRE SPA | MESALAMINE USP-EP |
| 16431 | I | II | 2/17/2003 | SUN PHARMACEUTICAL INDUSTRIES LTD | MESALAMINE USP (5-AMINO SALICYLIC ACID) |
| 18054 | I | II | 2/2/2005 | SIMS SRL | MESALAMINE |
| 18387 | I | II | 5/27/2005 | DR REDDYS LABORATORIES LTD | MESALAMINE |
| 18742 | A | II | 9/9/2005 | INFAR SA | 5-AMINOSALICYLIC ACID I (MESALAMINE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
