Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214331
Company: BAXTER HLTHCARE CORP

Products on ANDA 214331

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP1	No	No
ACETAMINOPHEN	ACETAMINOPHEN	650MG/65ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214331

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214331

ACETAMINOPHEN

SOLUTION;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP1

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	No	AP1	216617	ASPIRO
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	214331	BAXTER HLTHCARE CORP
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	219096	CAPLIN
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	210969	EUGIA PHARMA
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	202605	HIKMA
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	215403	INFORLIFE
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	213255	MYLAN
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	204052	SANDOZ
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP1	205746	WOCKHARDT BIO AG