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Last Updated: January 23, 2020

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Drug Master Files for: betaxolol hydrochloride

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betaxolol hydrochloride Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10727 A II 2/4/1994 LUSOCHIMICA SPA BETAXOLOL HYDROCHLORIDE
12638 I II 8/29/1997 ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV BETAXOLOL HYDROCHLORIDE, USP
12680 I II 10/2/1997 SIFAVITOR SRL BETAXOLOL HYDROCHLORIDE
13279 I II 10/19/1998 FINORGA SAS LEVOBETAXOLOL HYDROCHLORIDE
17235 A II 2/16/2004 OLON SPA BETAXOLOL HYDROCHLORIDE
25301 A II 9/22/2011 INDOCO REMEDIES LTD BETAXOLOL HYDROCHLORIDE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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