Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219239
Company: GLAND

Products on ANDA 219239

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINEPHRINE	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	No
EPINEPHRINE	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219239Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 219239

EPINEPHRINE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; 10MG/10ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPINEPHRINE	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	205029	BPI LABS
EPINEPHRINE	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	219239	GLAND

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPINEPHRINE	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	205029	BPI LABS
EPINEPHRINE	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	219239	GLAND