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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217131
Company: FRESENIUS KABI USA

Products on ANDA 217131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASCORBIC ACID	ASCORBIC ACID	25,000MG/50ML (500MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217131

ASCORBIC ACID

SOLUTION;INTRAVENOUS; 25,000MG/50ML (500MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASCOR	ASCORBIC ACID	25,000MG/50ML (500MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209112	MCGUFF
ASCORBIC ACID	ASCORBIC ACID	25,000MG/50ML (500MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217131	FRESENIUS KABI USA

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