Drug Master Files for: POSACONAZOLE

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POSACONAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24346	A	II	11/5/2010	SANDOZ PRIVATE LTD	POSACONAZOLE
27614	A	II	10/11/2013	MSN LABORATORIES PRIVATE LTD	POSACONAZOLE AMORPHOUS [ROUTE CODE PKA]
27720	A	II	11/22/2013	MSN LABORATORIES PRIVATE LTD	POSACONAZOLE (FORM-I) [ROUTE CODE - PJ1]
28223	A	II	1/5/2017	ALP PHARM BEIJING CO LTD	POSACONAZOLE FOMR I
28314	A	II	6/10/2014	BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD	POSACONAZOLE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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