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FDA ANDA · ANDA077117
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Sponsor: APOTEX INC
APPLICATION
ANDA077117
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-31
LATEST ACTION
2014-02-28
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEDiscontinued
ALBUTEROL SULFATE EQ 0.083% BASE, IPRATROPIUM BROMIDE 0.017% · SOLUTION · INHALATION
Approval history
2014-02-28Labeling · Supplement 2 · standardAP
2007-12-31OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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