Drug Master Files for: PROTIRELIN

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PROTIRELIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10251	I	II	5/14/1993	ABBOTT LABORATORIES	PROTIRELIN (TRH)
12272	I	II	12/6/1996	AVENTIS PHARMA DEUTSCHLAND GMBH	BULK PROTIRELIN (THYROID RELEASING HORMONE; TRH) DRUG SUBSTANCE
6434	I	II	1/9/1984	HOFFMANN LA ROCHE INC	PROTIRELIN (THYROTROPIN RELEASING HORMONE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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