Actualizaciones regulatorias

The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.

The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.

The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.

Teva submitted ANDA080921 for its oral capsule product Vitamin A Solubilized, containing vitamin A palmitate (EQ 50,000 units). The product is listed as discontinued.

FDA approves ANDA 088184 for Hydroxyzine Hydrochloride injectable product by Fresenius Kabi USA, with multiple labeling and manufacturing submissions.

Pioneer Pharm's ANDA 087839 for an oral tablet of cyproheptadine hydrochloride 4 mg is listed by the FDA with a discontinued marketing status.

The FDA has approved ANDA087463 for the oral tablet Oxycet, containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen, manufactured by SpecGx LLC.

The FDA’s database shows ANDA088515 for TRILITRON, an oral tablet containing pseudoephedrine HCl 60 mg and triprolidine HCl 2.5 mg, marketed by Newtron Pharms and currently discontinued.

FDA grants approval for Torrent Pharmaceuticals' Zolpidem Tartrate oral tablets (5 mg and 10 mg) under ANDA077903, confirming prescription status and labeling updates.

The FDA approved ANDA077302 for Actavis Pharma’s oral extended‑release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate in multiple strengths.

The FDA has approved application ANDA077013 for pravastatin sodium tablets (10‑80 mg) from sponsor Pharmobedient; all listed product numbers are marked discontinued.

The FDA granted a tentative approval for Teva Pharm's ribavirin oral solution (40 mg/mL) under ANDA 077611.