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Generated: June 16, 2019

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Drug Master Files for: BENZYL ALCOHOL

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BENZYL ALCOHOL Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10253 A II 5/12/1993 NEULAND LABORATORIES LTD BENZYL ALBUTEROL, INTERMEDIATE
10268 I II 6/3/1993 WELLSPRING PHARMACEUTICAL CORP DIBENZYLINE (SK&F 688-A) SOLUTION FOR INJECTION
10602 I II 11/23/1993 BIOCHIMICA OPOS SPA 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID, 4-NITROBENZYL ESTER HC1
11746 I II 11/14/1995 PHARM ECO LABORATORIES INC (S)-N-BENZYL-N-[1,5,-BIS(4-PYRIDYL)-3-PENTYL]-3-(4CHLOROPHENYL)-2-{METHYL-[2-OXO-2-(3,4,5 TRIMETHOXYPHENYL)
DMF No. Status Type Submission Date Holder Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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