Drug Master Files for: PALBOCICLIB

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PALBOCICLIB Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
32273	A	II	3/23/2018	HETERO LABS LTD	PALBOCICLIB
32294	A	II	12/21/2017	MYLAN LABORATORIES LTD	PALBOCICLIB
32646	A	II	3/28/2018	DR REDDYS LABORATORIES LTD	PALBOCICLIB
32867	A	II	8/3/2018	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	PALBOCICLIB
32907	A	II	7/25/2018	APOTEX PHARMACHEM INC	PALBOCICLIB
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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