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Last Updated: January 17, 2020

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Drug Master Files for: OMEPRAZOLE; SODIUM BICARBONATE

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OMEPRAZOLE; SODIUM BICARBONATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11017 I II 8/2/1994 ESTEVE QUIMICA SA OMEPRAZOLE
11551 A II 6/9/1995 UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) OMEPRAZOLE
11794 A II 12/21/1995 ESTEVE QUIMICA SA OMEPRAZOLE
12605 A II 7/23/1997 QUIMICA SINTETICA SA OMEPRAZOLE
12694 A II 10/9/1997 ASTRAZENECA AB PRILOSEC MUPS TABLETS (OMEPRAZOLE MAGNESIUM)
12726 A II 10/31/1997 ASTRAZENECA AB OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE
12827 A II 1/21/1998 CIPLA LTD OMEPRAZOLE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

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