Teva gets ANDA approval for tolvaptan generic; Ziac label updated
Teva Pharmaceuticals received FDA approval for a generic tolvaptan tablet, while a labeling supplement for Ziac was also cleared.
Two FDA drug application actions for Teva were recorded this week.
- Teva Pharms Inc received original approval for an ANDA covering tolvaptan tablets in 15MG, 30MG, 45MG, 60MG, and 90MG strengths, with the submission status dated 2026-07-21.1
- Teva Branded Pharm received approval for a labeling supplement, numbered 44, for bisoprolol fumarate and hydrochlorothiazide, marketed as Ziac in 2.5MG/6.25MG, 5MG/6.25MG, and 10MG/6.25MG tablet strengths, with the submission status dated 2026-07-24.2
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