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FDA ANDA · ANDA207875

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Sponsor: SUN PHARM

APPLICATION
ANDA207875
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-07
LATEST ACTION
2025-02-24
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

2025-02-24Labeling · Supplement 7 · standardAP
2017-08-07UNKNOWN · Original · standardAP
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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