Drug Master Files for: AZILSARTAN KAMEDOXOMIL

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AZILSARTAN KAMEDOXOMIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28092	A	II	3/27/2014	MSN LABORATORIES PRIVATE LTD	AZILSARTAN KAMEDOXOMIL [ROUTE CODE AK]
28452	A	II	8/14/2014	HEC PHARM CO LTD	AZILSARTAN KAMEDOXOMIL NON-STERILE BULK DRUG SUBSTANCE
29488	A	II	6/30/2015	ALEMBIC PHARMACEUTICALS LTD	AZILSARTAN MEDOXOMIL MONOPOTASSIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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