Details for New Drug Application (NDA): 020733
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NDA 020733 describes SUBOXONE, which is a drug marketed by Indivior and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the SUBOXONE profile page.
The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 020733
| Tradename: | SUBOXONE |
| Applicant: | Indivior |
| Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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