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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 020645

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)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020645

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2005	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020645ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020645s000TOC.cfm

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020645s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020645Orig1s012ltr.pdf
01/10/2017	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/07/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/30/2011	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020645s008ltr.pdf

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

Therapeutic Equivalents for NDA 020645

AMMONUL

SOLUTION;INTRAVENOUS; 10%;10% (5GM/50ML;5GM/50ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMMONUL	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	020645	BAUSCH
SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207096	AILEX PHARMS LLC
SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208521	MAIA PHARMS INC
SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	205880	NAVINTA LLC

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