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27 thg 9, 2026•1 phút đọc
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).
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25 thg 9, 2026•1 phút đọc
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.
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19 thg 9, 2026•1 phút đọc
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.
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8 thg 9, 2026•1 phút đọc
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.
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30 thg 8, 2026•1 phút đọc
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.
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28 thg 8, 2026•1 phút đọc
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.