Drug Master Files for: promethazine hydrochloride

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promethazine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11888	A	II	3/8/1996	SIGMA ALDRICH IRELAND LTD	PROMETHAZINE HYDROCHLORIDE
18173	I	II	3/2/2005	WANBURY LTD	PROMETHAZINE HYDROCHLORIDE
1949	A	II	6/9/1972	SANOFI CHIMIE	PROMETHAZINE HCL
1955	I	II	6/19/1972	NAPP CHEMICALS INC	PROMETHAZINE HCL (THIS D ORIG HELD BY VITAMERICAN CORP BY DOLDER LTD
1974	I	II	8/2/1972	PHENCHEM INDUSTRIES LTD	PROMETHAZINE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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