ANDA 211287: Approval Letter, Routing Sheet, CRL

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