Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217521
Company: BE PHARMS
Company: BE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP2 | No | No |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP2 | No | No |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP2 | 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 |
|---|---|---|---|---|---|---|---|
| 06/26/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION;INTRAVENOUS; 10MG/ML (10MG/ML)
TE Code = AP2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP2 | 209968 | AVET LIFESCIENCES |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP2 | 217521 | BE PHARMS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP2 | 210696 | EUGIA PHARMA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP2 | 210665 | FRESENIUS KABI USA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP2 | 203826 | HIKMA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP2 | 210334 | MEITHEAL |
SOLUTION;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP2 | 217521 | BE PHARMS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP2 | 203826 | HIKMA |
SOLUTION;INTRAVENOUS; 100MG/10ML (10MG/ML)
TE Code = AP2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP2 | 217521 | BE PHARMS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP2 | 203826 | HIKMA |