Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204300
Company: AVADEL LEGACY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes No
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes No
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
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
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 = AP

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 AP 211079 AMNEAL PHARMS CO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210665 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210334 MEITHEAL
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210025 PAR STERILE PRODUCTS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208905 SANDOZ INC
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 203826 WEST WARD PHARM CORP
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204300 AVADEL LEGACY

SOLUTION;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP

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 AP 211078 AMNEAL PHARMS CO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210666 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210333 MEITHEAL
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210025 PAR STERILE PRODUCTS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208905 SANDOZ INC
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204300 AVADEL LEGACY

SOLUTION;INTRAVENOUS; 100MG/10ML (10MG/ML)
TE Code = AP

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 AP 211078 AMNEAL PHARMS CO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210666 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210333 MEITHEAL
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210025 PAR STERILE PRODUCTS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208905 SANDOZ INC
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204300 AVADEL LEGACY

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