Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215783
Company: INFORLIFE
Company: INFORLIFE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE IN SODIUM CHLORIDE | PHENYLEPHRINE HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/250ML 400MCG/ML | SOLUTION; INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/2026 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215783Orig1s000TAltr.pdf |