Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Multiple Submissions for Discontinued Hydrocodone/Acetaminophen Tablet
FDA records show approved manufacturing and labeling submissions for the discontinued oral tablet HYDROCODONE BITARTRATE AND ACETAMINOPHEN (500 mg/7.5 mg).
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA090468 for ZYFREL Oral Solution (Acetaminophen/Hydrocodone)
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081069 for Hydrocodeine Bitartrate and Acetaminophen Oral Capsule
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.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA090265 for Hydrocodone/Acetaminophen Tablets
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.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Multiple Labeling and REMS Updates for Hydrocodone Bitartrate/Ibuprofen Oral Tablet (ANDA 076604)
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.
Regulatory Updates
Aug 28, 2026•1 min read
FDA Approves Multiple Submissions for LORTAB (ANDA 087722)
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.