Application Nr Approved Date Route Status External Links
ANDA201013 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hydrocodone Bitartrate And Acetaminophentablets Are Indicated For The Management Of Relief Of Moderate To Moderatelysevere Pain, Pain Severe Enough To Require An Opioid Analgesic And For Whichalternative Treatments Are Inadequate. Limitations Of Use Because Of The Risks Of Addiction, Abuse, Andmisuse, With Opioids, Even At Recommended Doses [see Warnings ], Reserve Hydrocodonebitartrate And Acetaminophen Tablets For Use In Patients For Whom Alternativetreatment 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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