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Last Updated: November 30, 2023

Drug Master Files for: Hoffmann La Roche

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Hoffmann La Roche Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1007	I	II	11/1/1966	HOFFMANN LA ROCHE INC	COMPOSITION & GR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307
1037	I	II	3/1/1967	HOFFMANN LA ROCHE INC	PROTAMINE HCL, RO 6-1588/1
10481	I	I	9/17/1993	HOFFMANN LA ROCHE INC	FACILITY AND OPERATING PROCEDURES IN WELWYN GARDEN CITY, HERTFORDSHIRE, ENGLAND
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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