Drug Master Files for: Tris Pharma Inc
✉ Email this page to a colleague
Tris Pharma Inc Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23870 | A | II | 7/20/2010 | TRIS PHARMA INC | METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION) |
| 25909 | A | II | 4/18/2012 | TRIS PHARMA INC | METHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS) |
| 27314 | A | II | 7/26/2013 | TRIS PHARMA INC | COD-CPM ER ORAL SUSPENSION |
| 29361 | A | II | 7/17/2015 | TRIS PHARMA INC | HCD-CPM-PSEUD ER OS (HYDROCODONE POLISTIREX, CHLORPHENIRAMINE POLISTIREX AND PSEUDOEPHEDRINE POLISTIREX ER ORAL SUSPENSION) |
| 29687 | A | II | 11/3/2015 | TRIS PHARMA INC | COD-CPM-PSE ER ORAL SUSPENSION |
| 33094 | A | II | 9/11/2018 | TRIS PHARMA INC | OXYBATE EXTENDED RELEASE POWDER FOR ORAL SUSPENSION (EQ. TO 4.5 G OF SODIUM OXYBATE) (Cl) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
