Drug Master Files for: adapalene
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adapalene Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18756 | A | II | 9/12/2005 | GLENMARK PHARMACEUTICALS LTD | ADAPALENE USP |
| 18826 | A | II | 9/30/2005 | HELSINN ADVANCED SYNTHESIS SA | ADAPALENE |
| 18831 | I | II | 9/22/2005 | ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD | ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE) |
| 19169 | A | II | 2/9/2006 | EXCELLA GMBH AND CO KG | ADAPALENE |
| 19621 | A | II | 7/10/2006 | OLON SPA | ADAPALENE DRUG SUBSTANCE |
| 20064 | A | II | 12/13/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ADAPALENE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
