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Last Updated: November 25, 2024

Drug Master Files for: tamsulosin hydrochloride


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tamsulosin hydrochloride Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11761 I II 12/1/1995 ASTELLAS PHARMA INC TAMSULOSIN HYDROCHLORIDE
13878 I II 12/3/1998 ASTELLAS IRELAND CO LTD TAMSULOSIN HYDROCHLORIDE
17247 I II 3/19/2004 DR REDDYS LABORATORIES LTD TAMSULOSIN HYDROCHLORIDE
17318 A II 4/9/2004 LEK PHARMACEUTICALS DD TAMSULOSIN HYDROCHLORIDE
17688 A II 9/17/2004 CADILA HEALTHCARE LTD TAMSULOSIN HYDROCHLORIDE USP
17865 I II 12/6/2004 SUN PHARMACEUTICAL INDUSTRIES LTD TAMSULOSIN HYDROCHLORIDE USP
18067 I II 1/22/2005 TAI HENG INDUSTRY CO LTD TAMSULOSIN HYDROCHLORIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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