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Generated: April 21, 2019

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Drug Master Files for: PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

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PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16918 A II 10/19/2003 DIVI'S LABOTATORIES LTD PHENYLEPHRINE HYDROCHLORIDE USP
18057 A II 1/24/2005 CHENG FONG CHEMICAL CO LTD PHENYLEPHRINE HYDROCHLORIDE
18319 A II 5/6/2005 SYN-TECH CHEM AND PHARM CO LTD PHENYLEPHRINE HYDROCHLORIDE USP
18788 A II 9/20/2005 MALLADI DRUGS AND PHARMACEUTICALS LTD PHENYLEPHRINE AND SALT
18799 I II 9/20/2005 SHENZHEN ORIENTAL PHARMACEUTICAL CO LTD PHENYLEPHRINE HYDROCHLORIDE (API)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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