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Last Updated: March 29, 2024

Drug Master Files for: Alcon


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Alcon Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11354 I II 2/15/1995 SA ALCON COUVREUR NV MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PUURS, BELGIUM.
2179 I I 10/30/1973 LAFAYETTE PHARMACAL DIV ALCON LABORATORIES INC MANUFACTURING OPERATIONS
2336 I II 10/24/1974 ALCON LABORATORIES INC STEROID/ANTI-INFECTIVE OPHTH.COMBINATIONS;SAFETY/EFFICACY ANALYSIS
32694 A III 4/2/2018 SUZHOU VALCON TUBE CO LTD COLLAPSIBLE PLASTIC TUBES AND CLOSURES FOR PHARMACEUTICAL, FOOD, COSMETIC, INDUSTRIAL AND PERSONAL CARE PACKAGING
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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