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Last Updated: March 29, 2024

Drug Master Files for: alendronate sodium


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alendronate sodium Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14334 A II 8/6/1999 CIPLA LTD ALENDRONATE SODIUM USP
14983 I II 8/2/2000 ALCHYMARS SPA ALENDRONATE SODIUM
15409 A II 4/30/2001 APOTEX PHARMACHEM INC ALENDRONATE SODIUM TRIHYDRATE USP
15858 I II 2/12/2002 CHEMI SPA SODIUM ALENDRONATE
16129 A II 9/10/2002 SIGNA SA DE CV ALENDRONATE SODIUM TRIHYDRATE USP
16367 I II 1/17/2003 MEDICHEM SA ALENDRONATE SODIUM
16962 A II 11/17/2003 ZAKLADY FARMACEUTYCZNE POLPHARMA SA SODIUM ALENDRONATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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