Drug Master Files for: tromethamine

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tromethamine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10372	I	II	11/2/1993	SYNCHEM CHEMICALS PRIVATE LTD	KETOROLAC TROMETHAMINE
10599	I	II	11/29/1993	ANGUS CHEMICAL CO	TROMETHAMINE (TRIS AMINO)
10740	I	II	2/23/1994	DELMAR CHEMICALS INC	KETOROLAC TROMETHAMINE
11507	I	II	5/15/1995	MAPRIMED SA	KETOROLAC TROMETHAMINE
11736	I	II	11/3/1995	ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV	KETOROLAC TROMETHAMINE
11799	I	II	1/4/1996	CILAG AG	KETOROLAC TROMETHAMINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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