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Regulatory UpdatesAug 30, 2026•1 min read

FDA Approves ANDA083666 for Hydrochlorothiazide/Reserpine Oral Tablet

By the PharmaCountry team

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FDA has approved ANDA083666 submitted by Watson Labs for an oral tablet combining 50 mg hydrochlorothiazide and 0.125 mg reserpine; the product is listed as discontinued.

The U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) number ANDA083666 submitted by Watson Labs. The approved product is an oral tablet marketed under the brand name Hydrochlorothiazide w/ Reserpine. It contains 50 mg of hydrochlorothiazide and 0.125 mg of reserpine in a tablet dosage form. The FDA database lists the product's marketing status as discontinued. Submission history shows multiple manufacturing (CMC) submissions that received approval: submission 18 on 1982‑03‑29, 27 on 1986‑02‑25, 28 on 1987‑12‑04, 24 on 1983‑12‑06, 29 on 1988‑03‑08, 30 on 1988‑08‑26, and 31 on 1988‑11‑30.

Compiled by the PharmaCountry team · Source: FDA.gov

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