Drug Master Files for: pemoline
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pemoline Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11780 | A | II | 12/24/1995 | KATWIJK CHEMIE BV | PEMOLINE |
| 12238 | I | II | 12/5/1996 | HOECHST CELANESE CORP | PEMOLINE |
| 12449 | I | II | 4/3/1997 | PHARM ECO LABORATORIES INC | 2-AMINO-5-PHENYL-4(5H)-OXAZOLONE-(PEMOLINE) |
| 12796 | I | II | 12/15/1997 | ORGAMOL SA | PEMOLINE |
| 13865 | I | II | 11/24/1998 | MALLINCKRODT INC | PEMOLINE MALLINCKRODT CODE 1500 |
| 13919 | I | II | 12/29/1998 | PLIVA DD | PEMOLINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
