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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078623
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION;INHALATION Discontinued None No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% BASE 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
04/05/2010 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-1 Labeling-Package Insert

Label is not available on this site.

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