Regulatorische Updates

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

FDA records show approved manufacturing and labeling submissions for the discontinued oral tablet HYDROCODONE BITARTRATE AND ACETAMINOPHEN (500 mg/7.5 mg).

Cypress Pharm Inc.'s ZYFREL oral solution (acetaminophen 325 mg/15 mL and hydrocodone 7.5 mg/15 mL) received FDA approval under ANDA090468, with labeling supplements approved in 2016 and 2017.

FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as discontinued.

The FDA approved ANDA081069 for an oral capsule containing 5 mg hydrocodeine bitartrate and 500 mg acetaminophen, sponsored by Mikart. The product is listed as discontinued.

The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.

The FDA has approved ANDA076914 for a discontinued oral tablet combining 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, submitted by Graviti Pharms.

The FDA approved ANDA076609 for a 100 mg propoxyphene napyslate and 650 mg acetaminophen oral tablet submitted by Watson Labs Florida; the product is listed as discontinued.

Teva Canada is recalling a lot of Novo‑Gesic Forte 500 mg acetaminophen tablets due to possible phenolic resin or epoxy contamination that could injure the digestive system.

The FDA granted approval for ANDA089479, submitted by AM THERAP, for an oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate. The product is listed as discontinued.

FDA records show PROVAL #3 oral capsule, containing 325 mg acetaminophen and 30 mg codeine phosphate, is now discontinued. Sponsor: Solvay. ANDA085685.

The FDA's ANDA090265, submitted by CARACO, received approval on Dec 23, 2008 for three oral hydrocodone bitartrate/acetaminophen tablet strengths, now listed as discontinued.