Drug Master Files for: Hec Pharm Co Ltd

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Hec Pharm Co Ltd Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19443	A	II	3/20/2006	HEC PHARM CO LTD	ERYTHROMYCIN THIOCYANATE, PHARMACEUTICAL INTERMEDIATE BULK FORM
19444	A	II	3/20/2006	HEC PHARM CO LTD	ERYTHROMYCIN USP, NON-STERILE BULK FORM
20852	I	II	9/10/2007	HEC PHARM CO LTD	AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE
23762	A	II	4/20/2010	HEC PHARM CO LTD	ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM
24709	A	II	2/20/2011	HEC PHARM CO LTD	CLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM
26295	A	II	8/9/2012	HEC PHARM CO LTD	LEVOFLOXACIN NON-STERILE BULK 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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