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Last Updated: May 27, 2024

Drug Master Files for: TIMOLOL MALEATE


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TIMOLOL MALEATE Drug Master Files

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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