Drug Master Files for: ELTROMBOPAG OLAMINE

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ELTROMBOPAG OLAMINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26746	A	II	12/20/2012	HETERO DRUGS LTD	ELTROMBOPAG OLAMINE
28842	A	II	12/20/2014	MSN LABORATORIES PRIVATE LTD	ELTROMBOPAG OLAMINE [ROUTE CODE - EA]
31667	A	II	4/29/2017	RAKS PHARMA PVT LTD	ELTROMBOPAG OLAMINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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