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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL1400270 PT003 formoterol fumarate;glycopyrronium bromide Active ingredient Chemical Drugs Import Drug Application 2014-08-20 Pearl Therapeutics, Inc. Pearl Therapeutics Inc Certificate Issued 2015-11-04 view
JXHL1600010 PT010 budesonide;formoterol fumarate;glycopyrronium bromide Aerosol Chemical Drugs Import Drug Application 2016-02-16 Pearl Therapeutics, Inc. Pearl Therapeutics Inc Certificate Issued 2016-11-24 view
JXHL1500190 PT010 budesonide;formoterol fumarate;glycopyrronium bromide Aerosol Chemical Drugs Import Drug Application 2015-07-28 Pearl Therapeutics, Inc. Pearl Therapeutics Inc Certificate Issued 2016-06-08 view
JXHL1500191 PT010 budesonide;formoterol fumarate;glycopyrronium bromide Aerosol Chemical Drugs Import Drug Application 2015-07-27 Pearl Therapeutics, Inc. Pearl Therapeutics Inc Certificate Issued 2016-06-08 view
JXHL1500153 PT010 budesonide;formoterol fumarate;glycopyrronium bromide Aerosol Chemical Drugs Import Drug Application 2015-07-10 Pearl Therapeutics, Inc. Pearl Therapeutics Inc Certificate Issued 2016-06-08 view