Drug Master Files for: QUININE SULFATE

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QUININE SULFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17086	A	II	1/5/2004	BUCHLER GMBH	QUININE SULFATE, USP
19905	I	II	10/24/2006	PT SINKONA INDONESIA LESTARI	QUININE SULFATE USP
20951	I	II	9/3/2007	PT KIMIA FARMA PERSERO TBK	QUININE SULFATE
20952	I	II	9/3/2007	PT KIMIA FARMA PERSERO TBK	QUININE HYDROCHLORIDE
23415	I	II	12/15/2009	AANJANEYA LIFECARE LTD	QUININE SULPHATE USP DRUG SUBSTANCE
23605	I	II	2/22/2010	AANJANEYA LIFECARE LTD	QUININE HYDROCHLORIDE EP DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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