Drug Master Files for: paliperidone
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paliperidone Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18915 | A | II | 11/29/2005 | JANSSEN PHARMACEUTICA NV | PALIPERIDONE (R076477) DRUG SUBSTANCE |
| 20902 | A | II | 10/24/2007 | JANSSEN PHARMACEUTICA NV | PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCE |
| 23129 | A | II | 10/7/2009 | JUBILANT GENERICS LTD | PALIPERIDONE |
| 23338 | A | II | 2/20/2010 | UNIMARK REMEDIES LTD | PALIPERIDONE |
| 23367 | A | II | 12/14/2009 | MYLAN LABORATORIES LTD | PALIPERIDONE USP |
| 23830 | A | II | 5/24/2010 | PAR A TECHNOLOGIES PRIVATE LTD | PALIPERIDONE (NON-STERILE BULK DRUG SUBSTANCE) |
| 23871 | A | II | 11/29/2010 | CADILA PHARMACEUTICALS LTD | PALIPERIDONE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
