Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203826
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMMPHENTIV | PHENYLEPHRINE HYDROCHLORIDE | 0.5MG/5ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| IMMPHENTIV | PHENYLEPHRINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP2 | Yes | Yes |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP2 | Yes | Yes |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP2 | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/20/2012 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203826s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203826Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826_phenylephrine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/09/2023 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203826Orig1s015,017ltr.pdf | |
| 03/09/2023 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203826Orig1s015,017ltr.pdf | |
| 06/19/2019 | SUPPL-9 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203826s009lbl.pdf | ||
| 12/09/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2016 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203826s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203826Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/09/2023 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf | |
| 03/09/2023 | SUPPL-15 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf | |
| 06/19/2019 | SUPPL-9 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203826s009lbl.pdf | |
| 09/06/2016 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203826s002lbl.pdf | |
| 12/20/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203826s000lbl.pdf |
IMMPHENTIV
There are no Therapeutic Equivalents.
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 |