Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204300
Company: EXELA PHARMA
Company: EXELA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP1 | Yes | Yes |
VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP1 | Yes | Yes |
VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP1 | 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 |
---|---|---|---|---|---|---|---|
06/27/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204300lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204300Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204300Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204300Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/20/2020 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204300Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204300Orig1s011ltr.pdf | |
10/18/2019 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204300s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204300Orig1s008ltr.pdf | |
05/28/2015 | SUPPL-5 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204300Orig1s005ltr.pdf |
10/29/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/02/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/20/2020 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204300Orig1s011lbl.pdf | |
03/20/2020 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204300Orig1s011lbl.pdf | |
10/18/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204300s008lbl.pdf | |
06/27/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204300lbl.pdf |
VAZCULEP
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 |
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 | 218110 | ASPIRO |
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 | 210025 | ENDO OPERATIONS |
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 | 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 | 218110 | ASPIRO |
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 | 210025 | ENDO OPERATIONS |
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 | 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 |