Regulatorische Updates

The FDA granted a Tentative Approval for Dr Reddys Labs' ANDA 077798, covering oral tablets of Escitalopram Oxalate in 5 mg, 10 mg, and 20 mg strengths.

The FDA has approved a series of supplemental submissions for the oral tablet Amitriptyline Hydrochloride (product 002), originally approved in 1977, now listed as discontinued.

The FDA has approved application ANDA086148 submitted by Roxane for a 150 mg oral tablet of amitriptyline hydrochloride, now listed as discontinued.

The FDA granted approval for ANDA 085231, an oral tablet containing 25 mg pyrilamine maleate, submitted by Watson Labs. The product is listed as discontinued.

The FDA has granted approval (ANDA081213) for Watson Labs' ESTROPIPATE 0.75 mg oral tablet, with several labeling and manufacturing submissions approved.

The FDA record for ANDA088630 shows TEVA's TRIPHED oral tablet, containing pseudoephedrine HCl 60 mg and triprolidine HCl 2.5 mg, is now marked discontinued.

The FDA has approved Teva Pharmaceuticals’ generic olanzapine oral tablets (5‑20 mg) under ANDA 077243, with several labeling supplements filed since 2014.

The FDA has marked the oral CHLORPHENIRAMINE MALEATE 4 mg tablet (product 001) from sponsor PVT FORM as discontinued under ANDA080786.

The FDA has approved Aurobindo Pharma’s pirfenidone tablets (ANDA 212596) for prescription use, available in 267 mg and 801 mg strengths.

The FDA granted approval for NDA020675 covering URSO 250 (250 mg) and URSO FORTE (500 mg) ursodiol tablets from Allergan, though both products are now listed as discontinued.

The FDA has approved ANDA076914 for a discontinued oral tablet combining 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, submitted by Graviti Pharms.

FDA has approved the ANDA206097 application for Zydus Pharm's prescription LINEZOLID 600 mg oral tablet, with labeling approvals up to July 2026.