Drug Master Files for: EPINEPHRINE BITARTRATE

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EPINEPHRINE BITARTRATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12037	A	II	7/10/1996	CAMBREX PROFARMACO MILANO SRL	NOREPINEPHRINE BITARTRATE OR NORADRENALINE ACID TARTRATE
15367	I	II	3/30/2001	WUHAN WUYAO PHARMACEUTICAL CO LTD	NOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG
16344	A	II	12/20/2002	CHEMPACIFIC CORP	NOREPINEPHRINE BITARTRATE
21213	A	II	12/31/2007	WOCKHARDT LTD	Epinephrine USP
21716	A	II	6/6/2008	AMRI RENSSELAER INC	RACEPINEPHRINE HYDROCHLORIDE, USP DRUG SUBSTANCE
25874	A	II	3/12/2012	DERIVADOS QUIMICOS SAU	RACEPINEPHRINE HYDROCHLORIDE
25989	A	II	4/13/2012	CAMBREX PROFARMACO MILANO SRL	EPINEPHRINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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