Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213206
Company: FRESENIUS KABI USA

Products on ANDA 213206

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213206

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213206

VASOPRESSIN

SOLUTION;INTRAVENOUS; 20UNITS/ML (20UNITS/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212944	AMNEAL
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211857	AMPHASTAR PHARMS INC
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213988	DR REDDYS
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211538	EAGLE PHARMS
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214314	EUGIA PHARMA
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213206	FRESENIUS KABI USA
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216963	GLAND PHARMA LTD
VASOSTRICT	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204485	ENDO OPERATIONS