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Last Updated: April 26, 2024

Drug Master Files for: Kv Pharm


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Kv Pharm Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10579 I II 11/16/1993 KV PHARMACEUTICAL CO MICONAZOLE VAGINAL CREAM
1147 I II 3/5/1968 VICTOR M HERMELIN AND CO DIV KV PHARMACAL CO PENTRITOL (PENTAERYTHRITOL TETRABUTRATE) TEMPULES 30MG C.R.C
1200 I II 7/5/1968 VICTOR M HERMELIN AND CO DIV KV PHARMACAL CO PENTRITOL (PENTAERYTHRITOL TETRANITRATE) TEMPULES 60MG CONT RLSE CAPSL
1224 I III 8/19/1968 VICTOR M HERMELIN AND CO DIV KV PHARMACAL CO DUOTRATE 30 PLATEAU CAPSULES
17321 I II 4/16/2004 KV PHARMACEUTICAL CO DESTAB(TM) FERROUS FUMARATE 90 S ULTRA
1813 I II 10/18/1971 KV PHARMACEUTICAL CO ORTHO-NOVUM 1/5OE21
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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