Drug Master Files for: OLOPATADINE HYDROCHLORIDE

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OLOPATADINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11801	A	II	1/10/1996	KYOWA HAKKO KIRIN CO LTD	OLOPATADINE HYDROCHLORIDE (KW 4679)
19417	A	II	5/9/2006	URQUIMA SA	OLOPATADINE HYDROCHLORIDE
19526	A	II	6/14/2006	CRYSTAL PHARMA SAU	OLOPATADINE HYDROCHLORIDE (PROCESS I)
22430	A	II	1/7/2009	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	OLOPATADINE HCL
23240	A	II	10/30/2009	FIS FABBRICA ITALIANA SINTETICI SPA	OLOPATADINE HYDROCHLORIDE
23908	A	II	6/18/2010	PCAS	OLOPATADINE HCL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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