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Last Updated: March 29, 2024

Drug Master Files for: atenolol


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atenolol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11134 I II 10/3/1994 SYNCHEM CHEMICALS PRIVATE LTD ATENOLOL
12149 I II 10/7/1996 IPR PHARMACEUTICALS INC ATENOLOL BULK DRUG
14210 A II 6/14/1999 CADILA HEALTHCARE LTD ATENOLOL USP
15037 A II 9/8/2000 IPCA LABORATORIES LTD ATENOLOL USP
17868 I II 12/21/2004 TIANJIN CENTRAL PHARMACEUTICAL CO LTD ATENOLOL USP
19672 I II 7/10/2006 PHARMAZELL INDIA PRIVATE LTD ATENOLOL USP
20268 I II 2/13/2007 WANBURY LTD ATENOLOL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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