FDA Approves AstraZeneca ISOETHARINE Inhalation (ANDA089615)

The FDA has approved the Abbreviated New Drug Application (ANDA) number ANDA089615 for an inhalation solution containing ISOETHARINE HYDROCHLORIDE. The product, marketed by AstraZeneca, is identified as ISOETHARINE HYDROCHLORIDE, dosage form solution, route inhalation, strength 0.125%, product number 001, and is not a reference drug or reference standard. Its marketing status is listed as discontinued. Submission history shows an original submission approved on June 13, 1991, and a supplemental labeling submission approved on November 16, 1992.