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FDA ANDA · ANDA076156

IPRATROPIUM BROMIDE

Sponsor: APOTEX INC

APPLICATION
ANDA076156
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-18
LATEST ACTION
2015-11-18
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

IPRATROPIUM BROMIDEPrescription
IPRATROPIUM BROMIDE 0.021MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2015-11-18Labeling · Supplement 20 · standardAP
2009-03-03Labeling · Supplement 13AP
2003-04-18OriginalReviewAP
VIEW ON DRUGS@FDA ↗

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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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