Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077117
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% 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
12/31/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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