Drug Master Files for: SERTRALINE HYDROCHLORIDE

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SERTRALINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14437	A	II	10/5/1999	CIPLA LTD	SERTRALINE HYDROCHLORIDE USP (FORM-V)
15731	A	II	11/14/2001	HETERO DRUGS LTD	SERTRALINE HCL USP (FORM II PROCESS I)
16009	A	II	6/11/2002	DR REDDYS LABORATORIES LTD	SERTRALINE HYDROCHLORIDE (FORM II)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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