Regulatorische Updates

The FDA has approved several manufacturing (CMC) supplement submissions for Sandoz’s Orphenadrine Citrate extended‑release tablet (ANDA 085046), which is currently listed as discontinued.

FDA approved Sandoz's ANDA090137 covering two Irinotecan Hydrochloride injectable products, both listed with discontinued marketing status.

Sandoz's ANDA078674 for oral rosiglitazone maleate tablets (2 mg, 4 mg, 8 mg) has received tentative approval from the FDA as of March 9 2009.

The FDA has approved ANDA085785 for Sandoz’s oral tablet of trifluoperazine hydrochloride, a prescription drug, with multiple manufacturing and labeling approvals spanning 1982‑1999.

The FDA approved ANDA085034 for ALPHAZINE, a 35 mg phendimetrazine tartrate oral tablet by Sandoz, with original and supplemental approvals spanning 1978‑1991.

The FDA approved Sandoz's ANDA 076231 for a 0.3% OFLOXACIN ophthalmic solution, though the product is listed as discontinued.

Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.

The FDA has approved Sandoz’s over‑the‑counter children’s cetirizine hydrochloride chewable tablets (5 mg and 10 mg) under ANDA 078692.

Sandoz received FDA approval for a generic ondansetron hydrochloride injection (preservative‑free) under ANDA 077551, with original and supplemental labeling approvals dating from 2007 to 2015.

The FDA has approved Sandoz's ANDA076873 for a prescription oral metformin hydrochloride 500 mg extended‑release tablet, with multiple labeling supplements approved.

The FDA approved Sandoz's ANDA084617 for the oral tablet DRALSERP containing hydralazine hydrochloride 25 mg and reserpine 0.1 mg; the product is listed as discontinued.

The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.