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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

#IVAX ×

UPDATED
Regulatorische Updates
24. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA083784 for Meclizine Hydrochloride 12.5 mg Tablet
The FDA approved ANDA083784 for a 12.5 mg oral Meclizine Hydrochloride tablet submitted by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
UPDATED
Regulatorische Updates
13. Sept. 2026•1 Min. Lesezeit
FDA Approves Reserpine and Hydroflumethiazide Tablet (ANDA 088932)
The FDA granted approval (AP) for ANDA 088932 submitted by IVAX PHARMS for an oral tablet containing 0.125 mg reserpine and 50 mg hydroflumethiazide; the product is listed as discontinued.
UPDATED
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Discontinues FLUTEX Topical Ointment (ANDA087377)
FDA records indicate the FLUTEX topical ointment (0.1% Triamcinolone Acetoinide) by IVAX PHARMS is discontinued, with original ANDA approval in 1988 and a labeling supplement in 1992.
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