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Last Updated: December 28, 2024

Drug Master Files for: naphazoline hydrochloride


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naphazoline hydrochloride Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10667 A II 1/12/1994 LOBA FEINCHEMIE GMBH NAPHAZOLINE HYDROCHLORIDE
11066 I II 9/2/1994 JOHNSON MATTHEY INC NAPHAZOLINE HYDROCHLORIDE
23642 I II 3/12/2010 ALP PHARM BEIJING CO LTD NAPHAZOLINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE)
23643 I II 3/12/2010 ALP PHARM BEIJING CO LTD NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE)
32465 A II 1/30/2018 MICRO LABS LTD NAPHAZOLINE HYDROCHLORIDE USP
32793 A II 4/16/2018 RANK ORGANICS CHEMICAL PVT LTD NAPHAZOLINE HCL USP
9709 I II 6/4/1992 CIBA GEIGY CORP PHARMACEUTICAL DIV NAPHAZOLINE HYDROCHLORIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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