Application Nr Approved Date Route Status External Links
ANDA074736 1997-01-21 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Pentazocine And Naloxone Tablets Are Indicated For The Management Of 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, Reserve Pentazocine And Naloxone 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 (2 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular

Active Ingredients ( 2 Total)