Actualizaciones regulatorias

The FDA records show original approval in 1974 and multiple supplemental approvals for the ophthalmic solution Naphazoline Hydrochloride, now listed as discontinued.

The FDA has approved the oral syrup formulation of ethosuximide (250 mg/5 ml) under ANDA 081306, with multiple manufacturing and labeling submissions listed.

The FDA has approved ANDA080630 for a 25 mg oral tablet of cortisone acetate, submitted by IVAX Sub Teva Pharm, with approval dated Jan 3 1972.

Quantum Pharmics filed ANDA 088972 for an oral tablet combining 50 mg butalbital, 325 mg aspirin, and 40 mg caffeine; the product is listed as discontinued.

The FDA database shows an ANDA (ANDA088660) for an oral tablet of thioridazine hydrochloride 25 mg submitted by West Ward, currently marked as discontinued.

The FDA has approved Mylan’s supplemental application (ANDA088332) for a 10 mg oral tablet of thioridazine hydrochloride, though the product is listed as discontinued.

FDA granted approval (status AP) for VANGARD's ANDA088010 covering a 10 mg oral capsule of chlordiazepoxide hydrochloride, listed as discontinued.

The FDA has approved ANDA 078338 for a prescription 1% clotrimazole topical cream marketed by Fougera Pharmas.

The FDA has granted approval for ANDA078039 submitted by CR DOUBLE CRANE for meloxicam oral tablets in 7.5 mg and 15 mg strengths. Both products are listed as discontinued.

The FDA has approved Mylan Pharmaceuticals' sumatriptan succinate tablets (25 mg, 50 mg, 100 mg) under ANDA 077744, with multiple labeling submissions recorded.

The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.

The FDA has approved ANDA076568 for Nicotine Polacrilex chewing gum, an over‑the‑counter nicotine replacement product available in 4 mg and 2 mg strengths.