FDA Approval for NALOXONE HYDROCHLORIDE issued to AMPHASTAR PHARMS INC
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 208969
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 4MG/0.25ML | SPRAY;NASAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 03/07/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
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