Actualizaciones regulatorias

The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.

The FDA records show multiple approved supplemental submissions for the discontinued 200 mg oral tablet of quinidine sulfate, covering manufacturing and labeling.

Pioneer Pharm's ANDA 087839 for an oral tablet of cyproheptadine hydrochloride 4 mg is listed by the FDA with a discontinued marketing status.

The FDA’s database shows ANDA088515 for TRILITRON, an oral tablet containing pseudoephedrine HCl 60 mg and triprolidine HCl 2.5 mg, marketed by Newtron Pharms and currently discontinued.

FDA grants approval for Torrent Pharmaceuticals' Zolpidem Tartrate oral tablets (5 mg and 10 mg) under ANDA077903, confirming prescription status and labeling updates.

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

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.

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.

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.