Drug Master Files for: apremilast
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apremilast Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 30248 | A | II | 4/6/2016 | LUPIN LTD | APREMILAST |
| 30332 | A | II | 3/29/2016 | MSN LIFE SCIENCES PRIVATE LTD | APREMILAST [ROUTE CODE LI] |
| 30732 | A | II | 9/30/2016 | DR REDDYS LABORATORIES LTD | APREMILAST (FORM B) |
| 30866 | A | II | 8/31/2016 | MSN LIFE SCIENCES PRIVATE LTD | APREMILAST (FORM-M) |
| 31141 | A | II | 11/9/2016 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | APREMILAST |
| 31159 | A | II | 12/23/2016 | MSN LIFE SCIENCES PRIVATE LTD | APREMILAST (AMORPHOUS) |
| 31180 | A | II | 12/29/2016 | RAKS PHARMA PVT LTD | APREMILAST |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
