規制動向

The FDA has approved ANDA078203 for Lorazepam tablets (0.5 mg, 1 mg, 2 mg) manufactured by Leading Pharma, LLC.

The FDA has approved Bausch & Lomb’s ophthalmic diclofenac sodium 0.1% solution (ANDA078792) for prescription use, confirming its safety and efficacy.

The FDA has approved labeling for Chartwell RX's fluticasone propionate nasal spray (ANDA078492), a prescription nasal spray.

The FDA has approved ANDA084590 for Sodium Pentobarbital 100 mg oral capsules by sponsor Anabolic; the product is listed as discontinued.

FDA records show approved manufacturing and labeling submissions for the discontinued oral tablet HYDROCODONE BITARTRATE AND ACETAMINOPHEN (500 mg/7.5 mg).

The FDA has listed the oral Nitrofurantoin 100 mg tablet (product 002) from Whiteworth Town PLsn as discontinued under ANDA 084085.

The FDA database shows ANDA080491 for a 5 mg oral tablet of Prednisone submitted by Elkins Sinn, currently marked as discontinued.

OCUCLEAR ophthalmic drops containing 0.025% oxyMetazoline hydrochloride have been discontinued; FDA records show a series of approved manufacturing and labeling submissions from 1986 to 2001.

The FDA has approved ANDA 087562 submitted by IDT Australia Ltd for a 50 mg oral tablet of dipyridamole, originally listed as discontinued.

The FDA record (ANDA083453) shows Halsey’s oral Niacin 500 mg tablet (product 001) is marked discontinued and is not a reference drug.

The FDA lists HEXASCRUB, a 3% hexachlorophene topical sponge, under application NDA018363 with a discontinued marketing status. Sponsor: PROF DSPLS.

FDA records indicate that PROCAN SR, an oral extended‑release tablet containing 250 mg procaineamide hydrochloride, has been discontinued. Sponsor Parke Davis filed multiple labeling submissions.