Regulatory Updates

The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.

FDA has approved Novitium Pharma's ANDA077550 covering discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) with original approval in 2015 and a labeling supplement in 2023.

FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.

FDA granted labeling approvals for Torrent Pharm's discontinued Alfuzosin Hydrochloride 10 mg extended‑release tablet (ANDA 079054).

FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.

FDA granted approval for ANDA077850, a generic nicotine polacrilex buccal gum (4 mg base) by IVAX Sub Teva Pharms, with labeling supplements approved in 2012 and 2013.

The FDA approved GYNE-LOTRIMIN, a clotrimazole 1% vaginal cream, in 1978 and issued multiple manufacturing and labeling supplements thereafter; the product is now discontinued for non‑safety reasons.

The FDA records show PAMELOR oral solution (nortriptyline hydrochloride) is discontinued, with a history of labeling and manufacturing submissions from 1977 to 2014.

FDA records indicate the oral Hydroxyzine Hydrochloride 50 mg tablet (product 001) is discontinued, with multiple manufacturing and labeling submissions approved between 1989 and 2016.

The FDA has granted several labeling approvals for Chartwell Rx’s desloratadine 5 mg oral tablet (ANDA078364), though the product is listed as discontinued.

The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.

Teva Pharmaceuticals’ oral ramipril capsule products (1.25‑10 mg) were listed as discontinued, with multiple FDA labeling supplements approved between 2008 and 2014.