Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA 085231 for Pyrilamine Maleate Oral Tablet by Watson Labs
The FDA granted approval for ANDA 085231, an oral tablet containing 25 mg pyrilamine maleate, submitted by Watson Labs. The product is listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
Epic Pharma receives FDA approval for Tizanidine Hydrochloride tablets (ANDA076347)
Epic Pharma LLC's ANDA076347 for prescription oral tablets of Tizanidine Hydrochloride (2 mg and 4 mg) has been approved by the FDA, with labeling submissions approved between 2007 and 2016.
Regulatory Updates
Sep 14, 2026•1 min read
Indonesian BPOM delegation visits Daewoong Pharma’s Magok R&D center to explore collaboration
An Indonesian BPOM pharmaceutical delegation toured Daewoong Pharmaceutical’s Magok R&D facility, reviewing new‑drug and biopharma projects and discussing joint development and approval pathways in Indonesia.
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Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Cipla Esomeprazole Magnesium ANDA078003
FDA granted approval for Cipla's ANDA078003 generic esomeprazole magnesium, covering two discontinued oral capsule products.
Regulatory Updates
Sep 12, 2026•1 min read
EMA CVMP Gives Positive Opinion on Cirbloc for Pig Immunisation
The Committee on Veterinary Medicinal Products adopted a positive opinion on the marketing authorisation of Cirbloc, a vaccine for active immunisation of pigs.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA206097 for LINEZOLID Oral Tablet
FDA has approved the ANDA206097 application for Zydus Pharm's prescription LINEZOLID 600 mg oral tablet, with labeling approvals up to July 2026.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Grants ANDA Approval for PHARMASCIENCE INC (ANDA205757)
The FDA issued a standard review tentative approval (TA) for ANDA205757 submitted by Pharmascience Inc., status dated Feb 15, 2019.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA208756 for Dexmethylphenidate Tablets (Rhodes Pharm)
The FDA has approved application ANDA208756 submitted by Rhodes Pharm for oral dexmethylphenidate hydrochloride tablets in 2.5 mg, 5 mg and 10 mg strengths, though the products are listed as discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA078384 for Carvedilol Tablets by Unichem Pharmaceuticals
The FDA has approved ANDA078384 for carvedilol oral tablets (3.125‑25 mg) manufactured by Unichem Pharmaceuticals and sponsored by Regcon Holdings.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA077182 for Desogestrel/Ethinyl Estradiol Oral Tablets
The FDA has approved ANDA077182 submitted by Dr. Reddys Labs SA for prescription oral tablets containing desogestrel and ethinyl estradiol, including multiple dosage strengths.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA 086892 for Chlordiazepoxide Hydrochloride Capsules
The FDA granted approval (ANDA 086892) for Lederle's oral capsule containing 5 mg chlordiazepoxide hydrochloride, listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA078152 for Oral Ondansetron Tablets (4 mg & 8 mg)
The FDA has approved ANDA078152 for prescription oral ondansetron tablets in 4 mg and 8 mg strengths, submitted by AvKARE, Glenmark and BluePoint.