Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217722
Company: HARM REDUCTION THERP
Company: HARM REDUCTION THERP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIVIVE | NALOXONE HYDROCHLORIDE | 3MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/28/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217722Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217722Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217722Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/28/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217722Orig1s000Lbl.pdf |
RIVIVE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPRAY, METERED;NASAL; 3MG/SPRAY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
RIVIVE | NALOXONE HYDROCHLORIDE | 3MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 217722 | HARM REDUCTION THERP |