Regulatory Updates

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.

FDA has approved ANDA077655 for valacyclovir hydrochloride oral tablets (500 mg and 1 g) from Teva Pharm, with original and supplemental labeling approvals.

SUN PHARM received FDA approval for ANDA077058 covering Pantoprazole Sodium delayed‑release tablets (20 mg and 40 mg). Multiple labeling supplements were approved between 2009 and 2015.

The FDA has approved several labeling supplement submissions for discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) under ANDA 076765.

The FDA has approved application ANDA079162 for generic topiramate oral tablets (25 mg, 50 mg, 100 mg, 200 mg) manufactured by Cipla USA Inc. and Exelan Pharmaceuticals.

FDA listed approval for ANDA078132 submitted by Northstar Healthcare covering oral ibuprofen tablets (400 mg, 600 mg, 800 mg) now marked discontinued.

FDA granted approval for ANDA078671 covering prescription NABUMETONE tablets (500 mg and 750 mg) from sponsor Invagen Pharms, manufactured by Exelan Pharmaceuticals and Cipla USA.

The FDA approved ANDA080126 on Jan 21 1972 for Everylife's STANOZIDE oral tablets containing 100 mg and 300 mg of isoniazid, both now listed as discontinued.

The FDA has approved labeling for generic levetiracetam tablets, 250 mg to 1 g, from BluePoint Laboratories and Aurobindo Pharma.

The FDA approved application ANDA078070 submitted by Pharmobedient for oral valacyclovir hydrochloride tablets (500 mg and 1 g equivalents). Both products are listed as discontinued.

The FDA approved generic ciprofloxacin hydrochloride tablets (250 mg, 500 mg, 750 mg) under ANDA 076593, sponsored by Aiping Pharm and manufactured by Westminster Pharmaceuticals.