Drug Master Files for: PIMOZIDE
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PIMOZIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10872 | I | II | 4/18/1994 | JANSSEN RESEARCH FDN | PIMOZIDE |
22747 | A | II | 4/23/2009 | UNIMARK REMEDIES LTD | PIMOZIDE USP [-2] |
25462 | A | II | 12/14/2011 | PAR PHARMACEUTICAL INC | PIMOZIDE USP |
27583 | A | II | 10/21/2013 | VASUDHA PHARMA CHEM LTD | PIMOZIDE USP |
28495 | A | II | 10/31/2014 | SAI LIFE SCIENCES LTD | PIMOZIDE USP |
8426 | I | II | 2/1/1990 | NV ORGANON | PIMOZIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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