Drug Master Files for: CODEINE SULFATE

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CODEINE SULFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10159	I	II	3/24/1993	NORAMCO DELAWARE INC	CODEINE SULFATE
10162	I	II	3/24/1993	NORAMCO DELAWARE INC	CODEINE
12655	I	II	9/11/1997	FINE CHEMICALS CORP	CODEINE PHOSPHATE
191	A	II	1/24/1956	SPECGX LLC	PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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