Regulatory Updates

FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.

The FDA granted approval (ANDA 086892) for Lederle's oral capsule containing 5 mg chlordiazepoxide hydrochloride, listed as discontinued.

The FDA approved GYNE-LOTRIMIN, a clotrimazole 1% vaginal cream, in 1978 and issued multiple manufacturing and labeling supplements thereafter; the product is now discontinued for non‑safety reasons.

The FDA records show PAMELOR oral solution (nortriptyline hydrochloride) is discontinued, with a history of labeling and manufacturing submissions from 1977 to 2014.

FDA records indicate the oral Hydroxyzine Hydrochloride 50 mg tablet (product 001) is discontinued, with multiple manufacturing and labeling submissions approved between 1989 and 2016.

The FDA approved ANDA083022 for the DODEX injectable containing 1 mg/mL cyanocobalamin. The product is listed as discontinued.

FDA has approved multiple manufacturing (CMC) and labeling submissions for the oral 65 mg Propoxyphe ne Hydrochloride capsule, now listed as discontinued.

Daewoong Bio was ordered by South Korea’s MFDS to halt production of its 300 mg Icosapent Ethyl soft capsules for one month after failing to process a consumer claim per its own standards.

The FDA has approved ANDA084712 for Bethanechol Chloride 10 mg tablets, marketed by Lannett, now listed as discontinued.

FDA NDA017406 for DICOPAC KIT, sponsored by GE Healthcare, indicates the product is discontinued and lists its submission history and active ingredients.

The FDA approved ECONOPRED, a 0.125% prednisolone acetate ophthalmic suspension, under NDA 017468 with multiple manufacturing submissions and a 2003 labeling approval. The product is now listed as discontinued.

The FDA database lists two discontinued oral tablet products named AMINOPHYLLIN (100 mg and 200 mg) and documents multiple labeling and manufacturing submissions approved between 1977 and 1991.