DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 018401
The generic ingredient in BUPRENEX 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 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 | Reckitt Benckiser Pharmaceuticals Inc | 12496-0757 | N | 12496-0757-5 |
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 |
Complete Access Available with Subscription