Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211079
Company: AMNEAL
Company: AMNEAL
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 | 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 |
---|---|---|---|---|---|---|---|
07/05/2018 | 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 |
---|---|---|---|---|---|
09/01/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/01/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION;INTRAVENOUS; 10MG/ML (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 | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 213237 | ACCORD HLTHCARE |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211079 | AMNEAL |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 218110 | ASPIRO |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 213318 | CAPLIN |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211920 | GLAND PHARMA LTD |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 218412 | HAINAN POLY |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 217069 | MANKIND PHARMA |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 211081 | PROVEPHARM SAS |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 209967 | SAGENT PHARMS INC |
PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP1 | 208905 | SANDOZ |
VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP1 | 204300 | EXELA PHARMA |