Drug Master Files for: doxylamine succinate

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doxylamine succinate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17417	I	II	5/21/2004	UQUIFA ITALIA SPA	DOXYLAMINE SUCCINATE USP
28027	A	II	2/6/2014	RL FINE CHEM PVT LTD	DOXYLAMINE SUCCINATE
31831	A	II	6/14/2017	SHENZHEN ORIENTAL PHARMACEUTICAL CO LTD	DOXYLAMINE SUCCINATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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