Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213988
Company: DR REDDYS

Products on ANDA 213988

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
VASOPRESSIN IN DEXTROSE 5%	VASOPRESSIN	40UNITS/100ML (0.4UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213988

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2026	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/03/2026	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213988

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	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
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212068	SANDOZ
VASOSTRICT	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204485	PH HEALTH

VASOPRESSIN IN DEXTROSE 5%

SOLUTION;INTRAVENOUS; 40UNITS/100ML (0.4UNITS/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VASOPRESSIN IN DEXTROSE 5%	VASOPRESSIN	40UNITS/100ML (0.4UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213988	DR REDDYS
VASOPRESSIN IN DEXTROSE 5%	VASOPRESSIN	40UNITS/100ML (0.4UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216963	GLAND
VASOSTRICT	VASOPRESSIN	40UNITS/100ML (0.4UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204485	PH HEALTH