The U.S. Food and Drug Administration (FDA) has granted approval for an Abbreviated New Drug Application (ANDA) identified as 088750. The approved product is an oral tablet containing 2.5 mg of methyclothiazide and is marketed under the brand name Methyclothiazide (product number 001). The FDA’s records list the marketing status of this tablet as discontinued.
The approval timeline includes two submissions. The original submission (ORIG) numbered 1 received approval on September 6, 1984. A supplemental submission (SUPPL) numbered 3, classified under Manufacturing (CMC), was approved on December 23, 1985.
The sponsor responsible for the application is Watson Labs.
Actualizaciones regulatorias16 sept 2026•3 min de lectura
FDA Approves Methyclothiazide Tablet (ANDA 088750)
The FDA has approved ANDA 088750 for a 2.5 mg oral tablet of methyclothiazide submitted by Watson Labs; the product is listed as discontinued.
Recopilado por el equipo de Pharmacountry · Fuente: FDA.gov
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