Drug Master Files for: LOTEPREDNOL ETABONATE

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LOTEPREDNOL ETABONATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11105	A	II	9/26/1994	ZACH SYSTEM SA	LOTEPREDNOL ETABONATE
11264	I	II	12/16/1994	FINE ORGANICS LTD	LO287 (CRUDE LOTEPREDNOL ETABONATE)
22278	I	II	12/2/2008	ALP PHARM BEIJING CO LTD	LOTEPREDNOL ETABONATE
23672	A	II	4/1/2010	INDUSTRIALE CHIMICA SRL	LOTEPREDNOL ETABONATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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