Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020645
Company: BAUSCH

• Label as it appears on Package

Products on NDA 20645

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMMONUL	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Labels for NDA 020645

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020645s012lbl.pdf
06/30/2011	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf
02/17/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf