Details for New Drug Application (NDA): 018401
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NDA 018401 describes BUPRENEX, which is a drug marketed by Indivior and is included in one NDA. Additional details are available on the BUPRENEX profile page.
The generic ingredient in BUPRENEX is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
The generic ingredient in BUPRENEX is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Summary for 018401
| Tradename: | BUPRENEX |
| Applicant: | Indivior |
| Ingredient: | buprenorphine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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