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FDA ANDA · ANDA202496
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Sponsor: RITEDOSE CORP
APPLICATION
ANDA202496
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-01
LATEST ACTION
2012-10-01
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEPrescription
ALBUTEROL SULFATE EQ 0.083% BASE, IPRATROPIUM BROMIDE 0.017% · SOLUTION · INHALATION
Approval history
2012-10-01UNKNOWN · OriginalAP
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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