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Last Updated: April 19, 2024

Drug Master Files for: pentosan

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pentosan Drug Master Files

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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
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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