규제 업데이트

The FDA has approved a series of manufacturing (CMC) and labeling submissions for the discontinued oral chlorthalidone 25 mg tablet (product 001, ANDA 087292).

The FDA has approved ANDA 088371 for a cyclophosphamide injectable product (100 mg/vial) marketed by Baxter Healthcare, with multiple manufacturing and labeling submissions approved.

The FDA’s ANDA088048 for a fluocinolone acetonide 0.01% topical solution submitted by Allied is listed as discontinued.

FDA issued an approval letter for ANDA 077780 covering carvedilol oral tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) submitted by TARO; all listed products are marked discontinued.

The FDA has approved Teva Pharmaceuticals’ ANDA 077487 for the oral tablet formulation of FAMCICLOVIR, available in 125 mg, 250 mg and 500 mg strengths.

The FDA’s ANDA 077179 approval covers oral capsule products of amlodipine besylate combined with benazepril hydrochloride, all listed as discontinued, with labeling submissions approved in 2011 and 2016.

The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.

The FDA approved application ANDA076605 for Ranbaxy’s oral gabapentin tablets (600 mg and 800 mg). Both products are currently listed as discontinued.

FDA approved Sun Pharm Industries Ltd's ANDA 076332 for Fluconazole oral suspension (200 mg/5 mL and 50 mg/5 mL). Both products are now discontinued.

Sandoz's ANDA078674 for oral rosiglitazone maleate tablets (2 mg, 4 mg, 8 mg) has received tentative approval from the FDA as of March 9 2009.

The FDA has issued labeling approvals for ANDA078380, a 20 mg sildenafil citrate tablet by Teva Pharmaceuticals, now listed as discontinued.

FDA approved a labeling supplement for Sun Pharm's amlodipine besylate tablets (2.5 mg, 5 mg, 10 mg) under ANDA078081; the products are currently listed as discontinued.