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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210334
Company: MEITHEAL

Products on ANDA 210334

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210334

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210334Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/09/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210334

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

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