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Last Updated: April 24, 2024

Drug Master Files for: Indoco Remedies


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Indoco Remedies Drug Master Files

DMF No. Status Type Submission Date Holder Subject
21097 I II 12/5/2007 INDOCO REMEDIES LTD Metformin Hydrochloride USP, as maufactured in Raigad District, INDIA
21239 A II 1/15/2008 INDOCO REMEDIES LTD ALLOPURINOL USP
21909 I II 8/11/2008 INDOCO REMEDIES LTD CIPROFLOXACIN HYDROCHLORIDE USP
22166 A II 10/29/2008 INDOCO REMEDIES LTD BRIMONIDINE TARTRATE
22295 A II 12/4/2008 INDOCO REMEDIES LTD DICYCLOMINE HYDROCHLORIDE USP
22565 A II 1/12/2009 INDOCO REMEDIES LTD GLIMEPIRIDE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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