Regulatorische Updates

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.

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

The FDA has approved a series of labeling and REMS submissions for the prescription oral tablet combining 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen under ANDA 076604.

The FDA’s ANDA 087722 for LORTAB (acetaminophen 500 mg/hydrocodone 5 mg oral tablet) includes a series of approved manufacturing and labeling submissions from 1984 to 1999; the product is now discontinued.