Drug Master Files for: IPRATROPIUM BROMIDE

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IPRATROPIUM BROMIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14259	A	II	6/25/1999	BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG	IPRATROPIUM BROMIDE MONOHYDRATE
15130	A	II	11/6/2000	NEULAND LABORATORIES LTD	IPRATROPIUM BROMIDE
21179	A	II	12/15/2007	AARTI INDUSTRIES LTD	IPRATROPIUM BROMIDE
23135	I	II	9/28/2009	DERIVADOS QUIMICOS SA FINE CHEMICALS	IPRATROPIUM BROMIDE
29843	A	II	10/1/2015	CIPLA LTD	IPRATROPIUM BROMIDE USP
31036	A	II	11/28/2017	AMPHASTAR NANJING PHARMACEUTICALS INC	IPRATROPIUM BROMIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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