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Last Updated: March 29, 2024

Drug Master Files for: Bh


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Bh Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10011 I II 12/14/1992 HEUMANN PHARMA GMBH AND CO TRIMETREXATE BASE
10035 A II 1/11/1993 CU CHEMIE UETIKON GMBH TERAZOSIN HYDROCHLORIDE
1004 I 10/21/1966 TROPONWERKE GMBH CO KG METHAQUALONE BASE AND HCL
10099 A IV 2/1/1993 DAIKIN REFRIGERANTS EUROPE GMBH 1,1,1,2,3,3,3-HEPTAFLUOROPROPANE (R-227) PROPELLANT GAS
10205 I III 4/15/1993 MAUSER WERKE GMBH PACKAGING MATERIAL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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