Apadaz Approval Status
- FDA approved: No
- Brand name: Apadaz
- Generic name: acetaminophen and benzhydrocodone hydrochloride
- Previous name: KP201
- Company: KemPharm, Inc.
- Treatment for: Pain
Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an investigational abuse-deterrent narcotic analgesic combination in development for the short-term management of acute pain.
On June 13, 2016, KemPharm, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Apadaz. A CRL indicates that the application is not ready for approval in its present form.
Development Status and FDA Approval Process for Apadaz
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