Drug Master Files for: NALOXEGOL OXALATE

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NALOXEGOL OXALATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
32535	A	II	3/3/2018	MSN LIFE SCIENCES PRIVATE LTD	NALOXEGOL OXALATE
32562	A	II	3/21/2018	MSN LIFE SCIENCES PRIVATE LTD	NALOXEGOL OXALATE (PREMIX)
33405	A	II	12/1/2018	AUROBINDO PHARMA LTD	NALOXEGOL OXALATE PREMIX
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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