Drug Master Files for: TRAMADOL HYDROCHLORIDE

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TRAMADOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11526	I	II	5/19/1995	IROTEC LABORATORIES	TRAMADOL HYDROCHLORIDE
11605	I	II	7/28/1995	HELSINN CHEMICALS SA	TRAMADOL HYDROCHLORIDE
11959	A	II	5/6/1996	WAVELENGTH ENTERPRISES LTD	TRAMADOL HYDROCHLORIDE
12404	I	II	2/28/1997	ZENTIVA AS	TRAMADOL HYDROCHLORIDE
12830	I	II	1/23/1998	WYCKOFF CHEMICAL CO INC	TRAMADOL HYDROCHLORIDE
12869	I	II	2/18/1998	EXCELLA GMBH	TRAMADOL HYDROCHLORIDE
14333	I	II	6/22/1999	SHIJIAZHUANG PHARMACEUTICAL GROUP CO LTD	TRAMADOL HYDROCHLORIDE USP (BULK)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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