Actualizaciones regulatorias

FDA has approved several oral risperidone tablet strengths ranging from 0.25 mg to 4 mg under ANDA 078269, with labeling submissions completed.

The FDA has approved ANDA 085767 for a 35 mg oral tablet of phendimetrazine tartrate submitted by Watson Labs; the product is listed as discontinued.

The FDA’s ANDA085276 for KV Pharma’s oral quinine sulfate 200 mg tablet is listed as discontinued, indicating it is no longer marketed.

The FDA has listed the injectable Trimethobenzamide Hydrochloride (product 001) from sponsor SoloPak as discontinued under ANDA 089094.

FDA granted approval for ANDA 088734, an oral 25 mg Meclizine Hydrochloride tablet by PLIVA. The product is listed as discontinued.

The FDA has listed the topical Triamcinolone Acetoinide 0.1% cream, sponsored by Morton Grove, as discontinued under ANDA 088095.

The FDA lists Copley Pharm’s oral Amitriptyline Hydrochloride 50 mg tablet (product #001) under ANDA 088423 as discontinued.

The FDA record NDA018047 shows approval of an injectable solution containing 10% dextrose and 0.9% sodium chloride, now listed as discontinued.

The FDA has approved Baxter Healthcare's intravenous potassium chloride, dextrose and sodium chloride injection (NDA018008) across several dosage strengths.

The FDA’s NDA 017952 record lists two discontinued oral Trimpex tablets (100 mg and 200 mg trimethoprim) and documents a series of approved manufacturing and labeling submissions spanning 1980‑1997.

The FDA database shows a prednisolone 5 mg oral tablet submitted under ANDA080236 by Valeant Pharmaceuticals International, currently marked as discontinued.

The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.