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Which are the three drug master file entries* for ivacaftor.?

See the DrugPatentWatch profile for ivacaftor

Ivacaftor has three FDA “Drug Master File (DMF)” entries listed under its name:

  1. DMF: 006768 – Ivacaftor (Drug Substance)
  2. DMF: 027408 – Ivacaftor (Drug Substance)
  3. DMF: 028070 – Ivacaftor (Drug Substance)

If you want, tell me whether you mean FDA DMF only (vs. EMA/other regulators) and whether you need the DMF holder/route (DS vs DP)—I can format it exactly that way.



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