Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Apotex Nizatidine Capsule ANDA 076383
FDA approved ANDA 076383 for Apotex Inc.'s oral Nizatidine capsules (150 mg and 300 mg) on Jan 23 2003; both products are listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077941 for Injectable Furosemide (10 mg/mL) by Apotex
The FDA has granted approval (ANDA077941) for Apotex's injectable furosemide 10 mg/mL, classified as a prescription product.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Apotex Generic Tizanidine Hydrochloride Capsules (ANDA078868)
The FDA has approved Apotex’s generic Tizanidine Hydrochloride oral capsules (2 mg, 4 mg, 6 mg) under application ANDA078868.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Apotex’s Albuterol Sulfate Inhalation Solution (ANDA 076391)
The FDA granted approval for Apotex Inc.’s ANDA 076391, an inhalation solution of albuterol sulfate, with original approval in 2003 and a labeling supplement in 2017.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Apotex Latanoprost Ophthalmic Solution (ANDA077697)
The FDA approved Apotex's ANDA077697 for a generic latanoprost ophthalmic solution, with labeling supplements approved in 2012 and 2015.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Apotex CILOSTAZOL (ANDA077030)
FDA has approved Apotex's oral cilostazol tablets (50 mg and 100 mg) under ANDA 077030, adding a generic phosphodiesterase‑3 inhibitor to the market.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Apotex Sotalol Hydrochloride Tablets (ANDA 076214)
The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.
Regulatory Updates
Aug 30, 2026•1 min read
Apotex Apo‑Semaglutide Injection Recall Due to Incorrect Dose Display
Apotex Inc. has recalled lot 700059A of its Apo‑Semaglutide 2 mg pen after the dose window may incorrectly show a 2 mg dose, delivering 2 mg instead of the intended 0.25 mg or 0.5 mg.