Details for New Drug Application (NDA): 211594
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The generic ingredient in BUPRENORPHINE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 211594
Tradename: | BUPRENORPHINE HYDROCHLORIDE |
Applicant: | Alvogen |
Ingredient: | buprenorphine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM;BUCCAL | Strength | EQ 0.075MG BASE | ||||
Approval Date: | Aug 3, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM;BUCCAL | Strength | EQ 0.15MG BASE | ||||
Approval Date: | Aug 3, 2021 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM;BUCCAL | Strength | EQ 0.3MG BASE | ||||
Approval Date: | Aug 3, 2021 | TE: | RLD: | No |
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