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Generated: September 22, 2019

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Drug Master Files for: albuterol

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albuterol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10253 A II 5/12/1993 NEULAND LABORATORIES LTD BENZYL ALBUTEROL, INTERMEDIATE
10254 I II 5/12/1993 NEULAND LABORATORIES LTD ALBUTEROL SULFATE
13840 I III 11/12/1998 COURTAULDS PACKAGING LTD ALBUTEROL 300 DOSE ACTUATOR PROJECT
14258 A II 6/25/1999 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG ALBUTEROL SULFATE (UNMICRONIZED)
16104 A II 8/16/2002 NEULAND LABORATORIES LTD ALBUTEROL USP
16130 I II 9/11/2002 NEULAND LABORATORIES LTD O-BENZYL ALBUTEROL INTERMEDIATE
16156 I III 10/1/2002 BESPAK INC ALBUTEROL ACTUATOR-CAP ASSEMBLY
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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