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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204300
Company: EXELA PHARMA

Summary Review

Products on NDA 204300

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204300

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.

Labels for NDA 204300

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

Therapeutic Equivalents for NDA 204300

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	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	213318	CAPLIN
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	210025	PAR STERILE PRODUCTS
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	213318	CAPLIN
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	210025	PAR STERILE PRODUCTS
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

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