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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220562
Company: HIKMA

Products on ANDA 220562

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220562

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220562

EPINEPHRINE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, 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;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	205029	BPI LABS
EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	220562	HIKMA

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