Drug Master Files for: haloperidol decanoate
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haloperidol decanoate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10946 | A | II | 6/13/1994 | JANSSEN PHARMACEUTICA NV | HALOPERIDOL (R001625) DRUG SUBSTANCE |
| 10954 | A | II | 6/23/1994 | JANSSEN PHARMACEUTICA NV | HALOPERIDOL DECANOATE |
| 12530 | A | II | 5/28/1997 | TEVA PHARMACEUTICAL INDUSTRIES LTD | HALOPERIDOL DECANOATE |
| 14226 | A | II | 6/22/1999 | EXCELLA GMBH AND CO KG | HALOPERIDOL |
| 15279 | I | III | 10/4/2000 | PLASDENE GLASS PAK | EFFECTS OF BIPERIDEN ON THE PHARMACOKINETICS OF HALOPERIDOL |
| 16949 | A | II | 11/10/2003 | OLON SPA | HALOPERIDOL DECANOATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
