Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075441
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/28/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75441ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-441_Ipratropium%20Bromide.pdf

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