Drug Master Files for: aztreonam

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aztreonam Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16751	I	II	8/8/2003	TEVA PHARMACEUTICAL INDUSTRIES LTD	AZTREONAM
17184	A	II	2/23/2004	EUTICALS SPA	AZTREONAM INTERMEDIATE NON-STERILE ALPHA-FORM
19342	A	II	4/11/2006	TEVA PHARMACEUTICAL INDUSTRIES LTD	AZTREONAM USP
20014	I	II	12/5/2006	ORCHID CHEMICALS AND PHARMACEUTICALS LTD	AZTREONAM
20907	I	II	9/7/2007	CHANGZHOU FANGYUAN PHARMACEUTICAL CO LTD	AZTREONAM, NON-STERILE BULK 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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