Last Updated: November 8, 2026

Drug Master Files for: SULINDAC

SULINDAC Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12224	A	II	11/15/1996	OLON SPA	SULINDAC
13018	I	II	6/10/1998	ZACH SYSTEM SPA	SULINDAC SULFONE
13089	I	II	7/21/1998	DIPHARMA SPA	SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY
16180	A	II	10/8/2002	DR REDDYS LABORATORIES LTD	SULINDAC USP
20104	I	II	12/28/2006	AGNO PHARMA USA	SULINDAC
20742	I	II	7/30/2007	FLAMMA SPA	SULINDAC
21102	A	II	11/28/2007	JIANGSU ZW PHARMACEUTICALS CO LTD	Sulindac USP BP-EP, Non-Sterile Drug Substance
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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