Application Nr Approved Date Route Status External Links
ANDA202214 2016-03-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hydrocodone Bitartrate And Acetaminophen Tablets Are Indicated For The Management Of Pain Severe Enough To Require 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 ], Reserve Hydrocodone Bitartrate 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 (4 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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