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Last Updated: March 18, 2024

Drug Master Files for: SILDENAFIL CITRATE


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SILDENAFIL CITRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17778 A II 10/25/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD SILDENAFIL CITRATE
19097 A II 1/10/2006 MYLAN LABORATORIES LTD SILDENAFIL CITRATE USP
21154 A II 12/13/2007 CADILA PHARMACEUTICALS LTD SILDENAFIL CITRATE USP
21250 I II 1/22/2008 SMS PHARMACEUTICALS LTD Sildenafil Citrate
21619 A II 5/15/2008 HETERO DRUGS LTD SILDENAFIL CITRATE
22037 A II 9/25/2008 DR REDDYS LABORATORIES LTD SILDENAFIL CITRATE
22142 A II 10/31/2008 TORRENT PHARMACEUTICALS LTD SILDENAFIL CITRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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