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Apadaz 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 History and FDA Approval Process for Apadaz

DateArticle
Jan  7, 2019Approval KemPharm 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, 2018Approval FDA 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
Apr 16, 2013KemPharm Advances KP201 Clinical and Commercial Program with Completion of Tablet Registration Activities
May 24, 2011KemPharm, Inc. Announces Positive Results from Phase 1 Trial of KP201 for Pain

Further information

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