Drug Master Files for: ROSIGLITAZONE MALEATE
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ROSIGLITAZONE MALEATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16594 | A | II | 5/14/2003 | DR REDDYS LABORATORIES LTD | ROSIGLITAZONE MALEATE USP (FORM III) |
| 17836 | I | II | 11/15/2004 | USV PRIVATE LTD | ROSIGLITAZONE MALEATE |
| 18931 | I | II | 11/4/2005 | CIPLA LTD | ROSIGLITAZONE MALEATE |
| 19404 | I | II | 5/1/2006 | BIOCON LTD | ROSIGLITAZONE MALEATE DRUG SUBSTANCE |
| 19894 | I | II | 10/23/2006 | SANDOZ PRIVATE LTD | ROSIGLITAZONE MALEATE |
| 19989 | A | II | 11/23/2006 | ITF CHEMICAL LTDA | ROSIGLITAZONE MALEATE |
| 21753 | I | II | 7/19/2008 | SUN PHARMACEUTICAL INDUSTRIES LTD | ROSIGLITAZONE MALEATE ANHYDROUS |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
