Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219215
Company: GLAND

Products on ANDA 219215

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219215

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219215

ACETAMINOPHEN

SOLUTION;INTRAVENOUS; 500MG/50ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAMINOPHEN	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204957	B BRAUN MEDICAL
ACETAMINOPHEN	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219215	GLAND

SOLUTION;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP2	204957	B BRAUN MEDICAL
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP2	219215	GLAND