Drug Master Files for: DEXMETHYLPHENIDATE HYDROCHLORIDE
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DEXMETHYLPHENIDATE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13228 | A | II | 9/21/1998 | SIEGFRIED USA LLC | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| 17117 | A | II | 1/23/2004 | LONZA INC | DEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL) |
| 20385 | A | II | 3/28/2007 | EUTICALS INC | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| 29784 | A | II | 10/7/2015 | AMPAC FINE CHEMICALS LLC | DEXMETHYLPHENIDATE HCl API |
| 30657 | A | II | 10/7/2016 | SPECGX LLC | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| 32902 | A | II | 6/23/2018 | ALKEM LABORATORIES LTD | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
