Drug Master Files for: IBUPROFEN

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IBUPROFEN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10165	A	II	3/26/1993	ADARE PHARMACEUTICALS INC	IBUPROFEN GELATIN/CAP
10499	A	II	9/29/1993	CATALENT PHARMA SOLUTIONS LLC	IBUPROFEN SOFTGELS, 200 MG.
11202	I	II	11/15/1994	UNITED BREWERIES LTD	IBUPROFEN USP
11243	I	II	11/29/1994	SHANDONG XIN HUA PHARMACEUTICAL FACTORY	IBUPROFEN BP 88/USP XXII
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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