Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217485
Company: AMNEAL

Products on ANDA 217485

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINEPHRINE	EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217485

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/14/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217485

EPINEPHRINE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADRENALIN	EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	204640	PH HEALTH
EPINEPHRINE	EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	217192	AM REGENT
EPINEPHRINE	EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	217485	AMNEAL
EPINEPHRINE	EPINEPHRINE	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211880	INTL MEDICATION SYS