Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217992
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/23/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NALOXONE HYDROCHLORIDE
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; 4MG/SPRAY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 217992 | AMNEAL |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 211951 | PADAGIS ISRAEL |
NARCAN | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 208411 | EMERGENT |