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Generated: December 19, 2018

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Drug Master Files for: ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 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
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
AstraZeneca
Julphar
Daiichi Sankyo
Express Scripts
Citi
Baxter
Teva

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