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Apadaz FDA Approval History

FDA Approved: Yes (First approved February 23, 2018)
Brand name: Apadaz
Generic name: acetaminophen and benzhydrocodone hydrochloride
Dosage form: Tablets
Previous Name: KP201
Company: KemPharm, Inc.
Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.

Development Timeline for Apadaz

DateArticle
Jan  7, 2019ApprovalKemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
Feb 23, 2018ApprovalFDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain
Jun 13, 2016FDA Issues Complete Response Letter for Apadaz New Drug Application
May  5, 2016Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz

Further information

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