Details for New Drug Application (NDA): 201066
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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-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 201066
Tradename: | BUPRENORPHINE HYDROCHLORIDE |
Applicant: | Mylan |
Ingredient: | buprenorphine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Mar 6, 2015 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE | ||||
Approval Date: | Mar 6, 2015 | TE: | RLD: | No |
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