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Last Updated: November 22, 2019

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Drug Master Files for: KETOROLAC TROMETHAMINE

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KETOROLAC TROMETHAMINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10372 I II 11/2/1993 SYNCHEM CHEMICALS PRIVATE LTD KETOROLAC TROMETHAMINE
10740 I II 2/23/1994 DELMAR CHEMICALS INC KETOROLAC TROMETHAMINE
11507 I II 5/15/1995 MAPRIMED SA KETOROLAC TROMETHAMINE
11688 I II 9/29/1995 DELMAR CHEMICALS INC KETOROLAC DERIVATIVE
11736 I II 11/3/1995 ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV KETOROLAC TROMETHAMINE
11799 I II 1/4/1996 CILAG AG KETOROLAC TROMETHAMINE
11980 A II 5/24/1996 QUIMICA SINTETICA SA KETOROLAC TROMETHAMINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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