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Generated: June 20, 2019

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Drug Master Files for: TRAMADOL HYDROCHLORIDE

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TRAMADOL HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11526 I II 5/19/1995 IROTEC LABORATORIES TRAMADOL HYDROCHLORIDE
11605 I II 7/28/1995 HELSINN CHEMICALS SA TRAMADOL HYDROCHLORIDE
11959 A II 5/6/1996 WAVELENGTH ENTERPRISES LTD TRAMADOL HYDROCHLORIDE
12404 I II 2/28/1997 ZENTIVA AS TRAMADOL HYDROCHLORIDE
12830 I II 1/23/1998 WYCKOFF CHEMICAL CO INC TRAMADOL HYDROCHLORIDE
12869 I II 2/18/1998 EXCELLA GMBH TRAMADOL HYDROCHLORIDE
14333 I II 6/22/1999 SHIJIAZHUANG PHARMACEUTICAL GROUP CO LTD TRAMADOL HYDROCHLORIDE USP (BULK)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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