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Details for New Drug Application (NDA): 018401
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NDA 018401 describes BUPRENEX, which is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Summary for 018401
| Tradename: | BUPRENEX |
| Applicant: | Indivior Inc |
| Ingredient: | buprenorphine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018401
| Mechanism of Action | Partial Opioid Agonists |
Suppliers and Packaging for NDA: 018401
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPRENEX | buprenorphine hydrochloride | INJECTABLE;INJECTION | 018401 | NDA | Indivior Inc. | 12496-0757 | 12496-0757-5 | 5 AMPULE in 1 CARTON (12496-0757-5) > 1 mL in 1 AMPULE (12496-0757-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.3MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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