Sandoz — Pharmaceutical Intelligence | Humanexa Signals

RegulatoryJune 28, 2026

Sandoz Issues Class 4 Medicines Defect Notification for Apixaban Tablets

Sandoz Ltd. reported that the Patient Information Leaflet for certain batches of Apixaban tablets lacks up-to-date information.

Recent signals(24)

FDA Grants AP Status for Sandoz's Leuprolide Acetate Supplement

FDA Grants Approval for Vasopressin Application ANDA212068 by Sandoz

FDA Approval Process Update for Vasopressin by Sandoz

Sandoz Receives FDA Approval for Sugammadex Sodium (ANDA214311)

FDA Accepts Supplemental Application for TYRUKO (Natalizumab-SZTN)

Sandoz's Enzalutamide ANDA216068 Receives Approval Status from FDA

Sandoz's Gabapentin ANDA075428 Receives Abbreviated Approval

FDA Accepts Supplemental NDA for Argatroban in Dextrose by Sandoz

Sandoz submits ANDA for Pemigatinib, seeking FDA approval

Sandoz Inc. Submits ANDA220465 for FDA Review

Sandoz submits ANDA for Tivozanib, marking a new generic entry

Sandoz Receives FDA Approval for Metformin Hydrochloride Supplement

Sandoz Inc. Submits ANDA220086 for FDA Review

FDA Accepts Supplemental Application for ZIEXTENZO by Sandoz

Sandoz Inc. Submits ANDA219346 for Review by FDA

Sandoz Receives FDA Approval for Vasopressin ANDA212069

Sandoz Receives FDA Approval for Vasopressin ANDA212068

Sandoz Receives FDA Approval for Liraglutide ANDA212972

Sandoz Receives FDA Approval for Enzalutamide ANDA216068

Sandoz Issues Class 4 Medicines Defect Notification for Apixaban Tablets

FDA Accepts Supplemental Application for Argatroban by Sandoz

Sandoz receives AP status for Irbesartan and Hydrochlorothiazide ANDA

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

Sandoz's Methylprednisolone ANDA040194 Receives AP Status from FDA

Upcoming catalysts

Regulatory activity(14)

FDA Grants AP Status for Sandoz's Leuprolide Acetate Supplement

FDA Grants Approval for Vasopressin Application ANDA212068 by Sandoz

FDA Approval Process Update for Vasopressin by Sandoz

FDA Accepts Supplemental Application for TYRUKO (Natalizumab-SZTN)

FDA Accepts Supplemental NDA for Argatroban in Dextrose by Sandoz

Sandoz submits ANDA for Pemigatinib, seeking FDA approval

Sandoz Inc. Submits ANDA220465 for FDA Review

Sandoz Receives FDA Approval for Metformin Hydrochloride Supplement

Sandoz Inc. Submits ANDA220086 for FDA Review

FDA Accepts Supplemental Application for ZIEXTENZO by Sandoz

Sandoz Issues Class 4 Medicines Defect Notification for Apixaban Tablets

FDA Accepts Supplemental Application for Argatroban by Sandoz

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

Sandoz's Methylprednisolone ANDA040194 Receives AP Status from FDA

Clinical activity

Competitive activity(2)

Sandoz Inc. Submits ANDA219346 for Review by FDA

Sandoz Receives FDA Approval for Vasopressin ANDA212069

Assets

Therapeutic areas

Indications

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