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Last Updated: September 19, 2020

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Drug Master Files for: MIDODRINE HYDROCHLORIDE

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MIDODRINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15610 I II 9/4/2001 CADILA HEALTHCARE LTD MIDODRINE HYDROCHLORIDE
16006 A II 6/13/2002 INDUSTRIALE CHIMICA SRL MIDODRINE HYDROCHLORIDE
16017 A II 6/21/2002 EDMOND PHARMA SRL MIDODRINE HYDROCHLORIDE
16135 A II 9/16/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE
16417 I II 2/6/2003 CHEMAGIS LTD MIDODRINE HYDROCHLORIDE
16481 A II 3/24/2003 ALCAMI WISCONSIN CORP MIDODRINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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