FDA ANDA · ANDA075693

IPRATROPIUM BROMIDE

Sponsor: RITEDOSE CORP

APPLICATION

ANDA075693

TYPE

ANDA

ORIGINAL APPROVAL

2001-01-26

LATEST ACTION

2013-05-20

ROUTE

RESPIRATORY (INHALATION), INHALATION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

IPRATROPIUM BROMIDEPrescription

IPRATROPIUM BROMIDE 0.02% · SOLUTION · INHALATION

2013-05-20Labeling · Supplement 21 · standardAP

2011-10-21Labeling · Supplement 15AP

2002-12-17Manufacturing (CMC) · Supplement 4AP

2002-05-07Manufacturing (CMC) · Supplement 3AP

2002-04-24Manufacturing (CMC) · Supplement 2AP

2001-10-11Labeling · Supplement 1AP

2001-01-26Original — Letter ↗AP

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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