Details for New Drug Application (NDA): 213195
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The generic ingredient in NALTREXONE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.
Summary for 213195
Tradename: | NALTREXONE |
Applicant: | Teva Pharms Usa Inc |
Ingredient: | naltrexone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 213195
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 380MG/VIAL | ||||
Approval Date: | Jul 6, 2023 | TE: | RLD: | No |
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