Details for New Drug Application (NDA): 020732
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NDA 020732 describes SUBUTEX, which is a drug marketed by Indivior and is included in one NDA. Additional details are available on the SUBUTEX profile page.
The generic ingredient in SUBUTEX 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 SUBUTEX 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 020732
| Tradename: | SUBUTEX |
| Applicant: | Indivior |
| Ingredient: | buprenorphine hydrochloride |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 8, 2002 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 8, 2002 | TE: | RLD: | Yes | |||||
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