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Generated: September 24, 2018

DrugPatentWatch Database Preview

Drug Master Files for: CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE

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CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10232 I II 3/6/1993 LABOCHIM SPA LEUCOVORIN CALCIUM
10238 I II 4/14/1993 BK LADENBURG GMBH DENTPHOS C (CALCIUM HYDROXYLAPATITE)
10759 I II 3/3/1994 AKZO NOBEL CHEMICALS BV DISSOLVINE E-CA-10 (EDETATE CALCIUM DISODIUM USP)
11685 I II 4/20/1995 SYNTHELABO PHARMACIE UREA-CALCIUM ACETYLSALICYLATE
11995 A II 6/10/1996 MERCK SANTE SAS CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE
1262 I II 12/16/1968 GENERAL ELECTRIC CO CALCIUM 45, PRODUCT SPECIFICATIONS AND PROCESS DESCRIPTIONS
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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