Drug Master Files for: TIMOLOL

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TIMOLOL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10690	A	II	1/25/1994	PCAS	TIMOLOL HEMIHYDRATE
10900	I	II	5/12/1994	VIALE FULVIO TESTI	TIMOLOL MALEATE
12234	I	II	11/22/1996	DEGUSSA AG WERK RADEBEUL	TIMOLOL MALEATE
14750	I	II	2/29/2000	SIFAVITOR SPA	TIMOLOL MALEATE
15516	A	II	7/4/2001	EXCELLA GMBH AND CO KG	TIMOLOL MALEATE
15580	A	II	8/10/2001	EXCELLA GMBH AND CO KG	TIMOLOL HEMIHYDRATE
23009	A	II	7/31/2009	SYN-TECH CHEM AND PHARM CO LTD	TIMOLOL MALEATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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