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 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 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| TABLET;SUBLINGUAL | Strength | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| TABLET;SUBLINGUAL | Strength | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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