Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018401
Company: INDIVIOR INC
Company: INDIVIOR INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPRENEX | BUPRENORPHINE HYDROCHLORIDE | EQ 0.3MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/17/2022 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018401s026lbl.pdf | |
10/07/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018401s025lbl.pdf |
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