Last Updated: November 13, 2026

Drug Master Files for: TOLBUTAMIDE

TOLBUTAMIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10388	I	II	7/30/1993	PHARMACEUTICAL WORKS POLPHARMA SA	TOLBUTAMIDE
25168	A	II	7/1/2011	KOTHARI PHYTOCHEMICALS INTERNATIONAL	TOLBUTAMIDE USP
2840	I	II	2/4/1977	DELMAR CHEMICALS INC	TOLBUTAMIDE (COARSE)
2841	I	II	2/4/1977	DELMAR CHEMICALS INC	TOLBUTAMIDE (FINE)
3139	A	II	2/28/1978	DIPHARMA FRANCIS SRL	TOLBUTAMIDE USP
3270	I	II	8/21/1978	MEDIMPEX NORTHAMERICA INC	TOLBUTAMIDE USP XIX
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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