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FDA ANDA · ANDA074755

IPRATROPIUM BROMIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA074755
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-10
LATEST ACTION
2012-12-07
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

IPRATROPIUM BROMIDEDiscontinued
IPRATROPIUM BROMIDE 0.02% · SOLUTION · INHALATION

Approval history

2012-12-07Labeling · Supplement 25 · standard — Label ↗AP
2007-02-20Manufacturing (CMC) · Supplement 17AP
2004-05-26Labeling · Supplement 15AP
2004-04-01Labeling · Supplement 13AP
2002-12-20Manufacturing (CMC) · Supplement 9AP
2002-12-20Manufacturing (CMC) · Supplement 7AP
2001-12-18Manufacturing (CMC) · Supplement 6AP
2001-01-31Manufacturing (CMC) · Supplement 5AP
2000-05-24Manufacturing (CMC) · Supplement 3AP
2000-05-24Manufacturing (CMC) · Supplement 4AP
1997-10-14Labeling · Supplement 1AP
1997-01-10OriginalAP
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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