Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210334
Company: MEITHEAL
Company: MEITHEAL
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/27/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210334Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/09/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
08/09/2023 | SUPPL-4 | Labeling-Package Insert |
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 |