APPLICATION
ANDA076749
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-31
LATEST ACTION
2012-08-13
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATE; IPRATROPIUM BROMIDEPrescription
ALBUTEROL SULFATE 0.5MG, IPRATROPIUM BROMIDE 0.017% · SOLUTION · INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEPrescription
ALBUTEROL SULFATE EQ 0.083% BASE, IPRATROPIUM BROMIDE 0.017% · SOLUTION · INHALATION
Approval history
2012-08-13Labeling · Supplement 14 · standardAP
2011-12-13Labeling · Supplement 12AP
2008-09-16Labeling · Supplement 1AP
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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