Details for New Drug Application (NDA): 205637
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The generic ingredient in BUNAVAIL 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 205637
Tradename: | BUNAVAIL |
Applicant: | Bdsi |
Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
Patents: | 4 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM;BUCCAL | Strength | EQ 2.1MG BASE;EQ 0.3MG BASE | ||||
Approval Date: | Jun 6, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | MAINTENANCE TREATMENT OF OPIOID DEPENDENCE | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 20, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 24, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 205637
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