Actualités réglementaires

FDA records show four discontinued oral tablet strengths of Clozapine and several approved REMS and labeling submissions spanning 2015‑2025.

FDA records indicate that Watson Labs' injectable product COBAVITE, containing 1 mg/mL cyanocobalamin, is listed as discontinued under ANDA083064.

The FDA granted approval (ANDA080718) for BEL MAR's thiamine hydrochloride injectable product, listed as discontinued.

FDA records show the oral tablet MEPROBAMATE (400 mg) is discontinued, with multiple manufacturing and labeling submissions approved between 1983 and 1999.

The FDA record shows Watson Labs' injectable Hydrocortisone Acetate (50 mg/mL) has been discontinued under ANDA085214.

DILOR-400, an oral tablet containing 400 mg theophylline, was approved under ANDA084751 with multiple manufacturing supplements; the product is currently discontinued.

The FDA approved ANDA 084286 submitted by BARR for a 2 mg oral tablet of Triamcinolone. The product is listed as discontinued.

FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.

Chartwell Rx’s oral tablet CAM-METRAZINE, containing 35 mg phendimetrazine tartrate, is listed as discontinued. The FDA ANDA record shows multiple manufacturing and labeling submissions.

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

The FDA has listed the oral prednisone 5 mg tablet (product 001) from sponsor HALSEY as discontinued under application ANDA080300.

The FDA records show that Watson Labs' potassium chloride injectable (3 mEq/mL) under ANDA 086210 is listed with a discontinued marketing status.