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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205880
Company: NAVINTA LLC

Products on ANDA 205880

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205880

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205880Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205880Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 205880

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205880Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205880

SODIUM PHENYLACETATE AND SODIUM BENZOATE

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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