Regulatory Updates

The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.

The FDA has approved a series of supplemental applications covering manufacturing and labeling for a discontinued 200 mg oral ibuprofen tablet (product 001).

FDA approved ANDA201251 submitted by Teva Pharm USA for two vancomycin hydrochloride injectable products (500 mg and 1 g per vial), both listed as discontinued.

The FDA has approved Eli Lilly’s Humulin R injectable insulin products, including OTC and prescription formulations, under application BLA018780.

The FDA has approved a series of manufacturing and labeling submissions for Indomethacin (NDA 018858). Both listed capsule products (25 mg and 50 mg) are marked discontinued.

The FDA approved ANDA 078873 for Teva’s methylphenidate hydrochloride extended‑release capsules (40 mg, 50 mg, 60 mg). All listed products are currently discontinued.

FDA has approved ANDA087129 for a 4 mg oral tablet of Cyproheptadine Hydrochloride, sponsored by Strides Pharma Intl, with a history of labeling and manufacturing supplements.

The FDA approved an ANDA (ANDA077678) for a 0.1% mometasone furoate topical lotion submitted by Cosette Pharms NC; the product is listed as discontinued.

FDA has approved ANDA 076507 submitted by TARO for oral Fluconazole tablets in 50‑200 mg strengths; all listed products are marked discontinued.

Health Canada has recalled three Organika gummy supplements after discovering they were imported from a foreign manufacturing site not listed on the site licence.

FDA approved application ANDA078102 submitted by TARO for meloxicam tablets (7.5 mg and 15 mg). Both products are listed with discontinued marketing status.

The FDA has approved a series of supplemental submissions for the oral tablet Amitriptyline Hydrochloride (product 002), originally approved in 1977, now listed as discontinued.