Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218144
Company: GLAND

Products on ANDA 218144

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Prescription	AP	No	No
EPINEPHRINE	EPINEPHRINE	10MG/10ML	INJECTION;SOLUTION,CONCENTRATE	None (Tentative Approval)	None	No	No
EPINEPHRINE	EPINEPHRINE	30MG/30ML	INJECTION;SOLUTION,CONCENTRATE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218144

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218144

EPINEPHRINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Prescription	Yes	AP	205029	BPI LABS
EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Prescription	No	AP	213708	FRESENIUS KABI USA
EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Prescription	No	AP	218144	GLAND