Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213708
Company: FRESENIUS KABI USA

Products on ANDA 213708

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213708

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