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ANDA 211287: Approval Letter, Routing Sheet, CRL

ANDA 211287: Approval Letter, Routing Sheet, CRL

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Documents associated with ANDA 211287:

  • Tentative approval letter
  • Final approval letter
  • Final approval routing sheet
  • Complete Response Letter

Abbreviated New Drug Application (ANDA): 211287
Company: LUPIN
Drug Name: TIOTROPIUM BROMIDE
Active Ingredients: TIOTROPIUM BROMIDE
Strength: EQ 0.018 MG BASE/INH
Dosage Form/Route: POWDER; NHALATION
Marketing Status: Prescription
TE Code: AB
Action Date: 06/20/2023

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