Application Nr Approved Date Route Status External Links
NDA208653 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Benzhydrocodone And Acetaminophen Tablets Are Indicated For The Short-Term (no More Than 14 Days) Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [see Warnings And Precautions (5.1)] , Reserve Benzhydrocodone And Acetaminophen Tablets For Use In Patients For Whom Alternative Treatment Options [e.g., Non-Opioid Analgesics]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia. Benzhydrocodone And Acetaminophen Tablets Is A Combination Of Benzhydrocodone, A Prodrug Of The Opioid Agonist Hydrocodone, And Acetaminophen, And Is Indicated For The Short-Term (no More Than 14 Days) Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. (1) Limitations Of Use (1) Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Benzhydrocodone And Acetaminophen Tablets For Use In Patients For Whom Alternative Treatment Options [e.g., Non-Opioid Analgesics]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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