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Last Updated: November 24, 2024

Drug Master Files for: LITHIUM CARBONATE


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LITHIUM CARBONATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1074 I II 6/27/1967 SOLVAY PHARMACEUTICALS MANUFACTURING CONTROL INFORMATION FOR--LITHIUM CARBONATE
1190 I II 5/24/1968 LYNE LABORATORIES INC LITHIUM CARBONATE TABLETS
1241 A II 9/30/1968 FMC LITHIUM SUB FMC CORP LITHIUM CARBONATE
1320 I II 2/10/1969 SOLVAY PHARMACEUTICALS LITHIUM CITRATE SYRUP
15677 A II 10/18/2001 LEK PHARMACEUTICALS DD LITHIUM CARBONATE A SUBSTANCE
1830 I II 12/9/1971 SIGMA CHEMICAL CO CARBAMYL PHOSPHATE, DILITHIUM SALT
19158 I II 2/3/2006 LIMTECH CARBONATE INC LITHIUM CARBONATE, USP GRADE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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