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Last Updated: November 23, 2024

Drug Master Files for: LEVODOPA


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LEVODOPA Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12379 A II 2/19/1997 AJINOMOTO CO INC LEVODOPA
12505 I II 5/15/1997 EGIS PHARMACEUTICALS PRIVATE LTD LEVODOPA USP BULK
1367 I II 5/7/1969 LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO LEVODOPA (COMPOUND 7550)
1649 I II 2/1/1971 GD SEARLE AND CO L-DOPA (OR LEVODOPA) IN BULK ONLY
17874 A II 12/3/2004 DIVIS LABORATORIES LTD LEVODOPA USP
20522 I II 5/8/2007 DELMAR CHEMICALS INC LEVODOPA METHYL ESTER HYDROCHLORIDE
2156 I 9/28/1973 LEPETIT LABS SA LEVODOPA (BULK)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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