Details for New Drug Application (NDA): 210162
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The generic ingredient in BUPRENORPHINE 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 210162
Tradename: | BUPRENORPHINE |
Applicant: | Mylan Tech Viatris |
Ingredient: | buprenorphine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210162
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 5MCG/HR | ||||
Approval Date: | May 3, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 7.5MCG/HR | ||||
Approval Date: | May 3, 2021 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 10MCG/HR | ||||
Approval Date: | May 3, 2021 | TE: | RLD: | No |
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