Drug Master Files for: ICATIBANT ACETATE

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ICATIBANT ACETATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20862	A	II	9/17/2007	BACHEM AG	ICATIBANT ACETATE
28496	A	II	3/9/2015	CHENGDU SHENGNUO BIOPHARM CO LTD	ICATIBANT ACETATE
29213	A	II	3/26/2015	BCN PEPTIDES SA	ICATIBANT ACETATE
29225	A	II	5/22/2015	AMBIOPHARM INC	ICATIBANT ACETATE (NON-STERILE)
30476	A	II	6/9/2016	TEVA PHARMACEUTICAL INDUSTRIES LTD	ICATIBANT ACETATE
30526	A	II	9/27/2016	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	ICATIBANT ACETATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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