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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204957
Company: B BRAUN MEDICAL

Products on NDA 204957

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204957

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204957s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204957Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204957Orig1s000TOC.html

Labels for NDA 204957

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204957s000lbl.pdf

Therapeutic Equivalents for NDA 204957

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

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