Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210666
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP1 | No | No |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP1 | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP1
| 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 | AP1 | 213237 | ACCORD HLTHCARE |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211078 | AMNEAL |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 213318 | CAPLIN |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210697 | EUGIA PHARMA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210666 | FRESENIUS KABI USA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211920 | GLAND PHARMA LTD |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 218412 | HAINAN POLY |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 217069 | MANKIND PHARMA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210333 | MEITHEAL |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210025 | PAR STERILE PRODUCTS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211081 | PROVEPHARM SAS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 209967 | SAGENT PHARMS INC |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 208905 | SANDOZ |
| VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP1 | 204300 | EXELA PHARMA |
SOLUTION;INTRAVENOUS; 100MG/10ML (10MG/ML)
TE Code = AP1
| 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 | AP1 | 213237 | ACCORD HLTHCARE |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211078 | AMNEAL |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 213318 | CAPLIN |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210697 | EUGIA PHARMA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210666 | FRESENIUS KABI USA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211920 | GLAND PHARMA LTD |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 218412 | HAINAN POLY |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 217069 | MANKIND PHARMA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210333 | MEITHEAL |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 210025 | PAR STERILE PRODUCTS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211081 | PROVEPHARM SAS |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 209967 | SAGENT PHARMS INC |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 208905 | SANDOZ |
| VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP1 | 204300 | EXELA PHARMA |