Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211857
Company: AMPHASTAR PHARMS INC

Products on ANDA 211857

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 211857

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211857Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 211857

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	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	PAR STERILE PRODUCTS