Drug Master Files for: bosutinib monohydrate

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bosutinib monohydrate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
30218	A	II	2/5/2016	MSN LABORATORIES PRIVATE LTD	BOSUTINIB [ROUTE CODE BS]
30278	A	II	2/26/2016	MSN LABORATORIES PRIVATE LTD	BOSUTINIB (FORM-R) [ROUTE CODE BY]
30552	A	II	6/30/2016	ALEMBIC PHARMACEUTICALS LTD	BOSUTINIB
30683	A	II	7/8/2016	MSN LABORATORIES PRIVATE LTD	BOSUTINIB MONOHYDRATE (FORM-I)
31218	A	II	12/12/2016	ALP PHARM BEIJING CO LTD	BOSUTINIB
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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