Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215617
Company: SOMERSET THERAPS LLC

Products on ANDA 215617

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215617

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215617Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215617

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;INTRAVENOUS; 0.5MG/5ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIORPHEN	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	212909	DR REDDYS LABS SA
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215617	SOMERSET THERAPS LLC