Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217569
Company: BAXTER HLTHCARE CORP

Products on NDA 217569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VASOPRESSIN IN SODIUM CHLORIDE 0.9%	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
VASOPRESSIN IN SODIUM CHLORIDE 0.9%	VASOPRESSIN	40UNITS/100ML (0.4UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217569s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217569Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217569Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217569Orig1s001lbl.pdf

Labels for NDA 217569

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217569Orig1s001lbl.pdf
09/29/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217569s000lbl.pdf