Drug Master Files for: acitretin
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acitretin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16580 | I | II | 5/12/2003 | SUN PHARMACEUTICAL INDUSTRIES LTD | ACITRETIN USP |
| 17001 | A | II | 12/1/2003 | OLON SPA | ACITRETIN |
| 21113 | A | II | 12/3/2007 | ZACH SYSTEM SA | Methoxy-C15-WITTIG Salt (TGN05), Intermediate for Acitretin API |
| 21373 | A | II | 2/25/2008 | CHEMPACIFIC CORP | CH011 (ACITRETIN) DRUG SUBSTANCE |
| 22090 | I | II | 10/9/2008 | BASF SE | ACITRETIN |
| 22358 | A | II | 12/29/2008 | SOLARA A PHARMA SCIENCES LTD | ACITRETIN |
| 23310 | A | II | 12/10/2009 | USV PRIVATE LTD | ACITRETIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
