Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202605
Company: HIKMA

Products on ANDA 202605

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202605

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2016	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202605

ACETAMINOPHEN

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

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