Drug Master Files for: FENTANYL HYDROCHLORIDE

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FENTANYL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10128	A	II	3/15/1993	SPECGX LLC	FENTANYL CITRATE (NEW PROCESS)
11200	A	II	11/15/1994	JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS	FENTANYL HYDROCHLORIDE
14284	I	II	6/30/1999	MALLINCKRODT LLC	FENTANYL HYDROCHLORIDE
14285	A	II	6/30/1999	SPECGX LLC	FENTANYL ALKALOID
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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