Drug Master Files for: methylphenidate
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methylphenidate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10137 | A | II | 3/5/1993 | JOHNSON MATTHEY INC | METHYLPHENIDATE HYDROCHLORIDE USP |
| 11635 | I | II | 8/31/1995 | UCB INC | METHYLPHENIDATE HYDROCHLORIDE, USP |
| 12769 | A | II | 11/25/1997 | SPECGX LLC | METHYLPHENIDATE HYDROCHLORIDE USP |
| 12989 | I | II | 5/15/1998 | SIEGFRIED USA LLC | METHYLPHENIDATE HYDROCHLORIDE USP |
| 13132 | A | II | 8/12/1998 | SPECGX LLC | METHYLPHENIDATE BASE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
