Drug Master Files for: PENTOSAN POLYSULFATE SODIUM
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PENTOSAN POLYSULFATE SODIUM Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
21248 | A | II | 1/10/2008 | BENE PHARMACHEM GMBH AND CO KG | PENTOSAN POLYSULFATE SODIUM (PPS), NON-STERILE BULK DRUG SUBSTANCE |
22582 | I | II | 2/20/2009 | ALEMBIC PHARMACEUTICALS LTD | PENTOSAN POLYSULFATE SODIUM |
22781 | I | II | 5/15/2009 | CF PHARMA LTD | PENTOSAN POLYSULFATE SODIUM |
25011 | A | II | 5/31/2011 | PARABOLIC DRUGS LTD | PENTOSAN POLYSULFATE SODIUM |
25827 | A | II | 2/22/2012 | SWATI SPENTOSE PVT LTD | PENTOSAN POLYSULFATE SODIUM |
31045 | A | II | 10/17/2016 | CF PHARMA LTD | PENTOSAN POLYFULFATE SODIUM |
31208 | A | II | 1/16/2017 | APICORE US LLC | PENTOSAN POLYSULFATE SODIUM |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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