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Last Updated: December 22, 2024

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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)
11898 I II 3/11/1996 CIS US INC META-IODOBENZYLGUANIDINE SULFATE (MIBG-S)
12200 I II 10/30/1996 INALCO SPA 2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-GLUCOPYRANOSIDE (DBEG)
12218 I I 11/12/1996 NIPPON SODA CO LTD 4-NITROBENZYL (4R,5R,6S)-3-DIPHENYLPHOSPHORYLOXY-6-[(R)-1-HYDROXYETHYL]-4-METHYL-7-OXO-1-AZABICYCLO[3.2.0.] HEPT-2-ENE-2-CARBOXYLATE (CODE NAME MAP), A BULK CHE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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