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FDA ANDA · ANDA076724

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Sponsor: TEVA PHARMS

APPLICATION
ANDA076724
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-31
LATEST ACTION
2016-12-29
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

2016-12-29Manufacturing (CMC) · Supplement 12AP
2012-08-13Labeling · Supplement 9 · standardAP
2011-12-21Labeling · Supplement 5AP
2009-12-11Labeling · Supplement 3AP
2007-12-31OriginalAP
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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