Drug Master Files for: PHENYLEPHRINE HYDROCHLORIDE

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PHENYLEPHRINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16918	A	II	10/19/2003	DIVI'S LABOTATORIES LTD	PHENYLEPHRINE HYDROCHLORIDE USP
18057	A	II	1/24/2005	CHENG FONG CHEMICAL CO LTD	PHENYLEPHRINE HYDROCHLORIDE
18319	A	II	5/6/2005	SYN-TECH CHEM AND PHARM CO LTD	PHENYLEPHRINE HYDROCHLORIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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