Regulatorische Updates

The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.

Teva submitted ANDA080921 for its oral capsule product Vitamin A Solubilized, containing vitamin A palmitate (EQ 50,000 units). The product is listed as discontinued.

The FDA has listed the Lactulose oral and rectal solution (product #001) as discontinued under NDA017906, sponsored by Solvay.

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.

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

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 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.

SUN PHARM INDS LTD's ANDA076786 for oral Donepezil Hydrochloride tablets (5 mg and 10 mg) has been approved by the FDA, with both products listed as discontinued.

The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.