Drug Master Files for: ERYTHROMYCIN STEARATE

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ERYTHROMYCIN STEARATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10087	I	II	4/11/1991	PHARMACIA AND UPJOHN	ERYTHROMYCIN ENTERIC-COATED TABLETS
12182	I	II	10/23/1996	METABOLIC SOLUTIONS INC	ERYTHROMYCIN BREATH TEST DOSE
13197	A	II	4/30/1998	ABBVIE INC	ERYTHROMYCIN BASE
13204	I	II	4/30/1998	LILLY RESEARCH LABORATORIES	ERYTHROMYCIN ESTOLATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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