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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210025
Company: PAR STERILE PRODUCTS

Products on ANDA 210025

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP1	No	No
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210025

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2020	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
07/27/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210025

PHENYLEPHRINE HYDROCHLORIDE

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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