Drug Master Files for: Specgx Llc

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Specgx Llc Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10123	I	II	3/9/1993	SPECGX LLC	ZICONOTIDE (SNX-111), CODE 8068
10128	A	II	3/15/1993	SPECGX LLC	FENTANYL CITRATE (NEW PROCESS)
11345	A	II	2/10/1995	SPECGX LLC	MEPERIDINE HYDROCHLORIDE, USP
11421	A	II	3/31/1995	SPECGX LLC	NALBUPHINE HYDROCHLORIDE (LOW BETA EPIMER) CODE 3310
12052	I	II	7/18/1996	SPECGX LLC	LEUPROLIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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