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Last Updated: September 30, 2023

Drug Master Files for: Sandoz Inc

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Sandoz Inc Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
4985	I	II	4/22/1983	SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC	GUANFACINE HYDROCHLORIDE
5191	I	V	9/8/1983	SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC	DATA FOR THE PHARMACOLOGY,TOXICOLOGY AND METABOLISM OF SOLULAN C-24
5610	I	II	12/3/1984	SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC	BUTALBITAL
5733	I	II	2/26/1985	SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC	PHENIRAMINE MALEATE
593	I	II	6/6/1963	SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC	INVESTIGATIONAL DRUGS
639	I		7/22/1963	DORSEY LABORATORIES DIV SANDOZ INC	VASCULAT (IS KNOWN IN GERMANY-USED TO IMPROVE PERIPHERAL CIRCULATION)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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