Details for New Drug Application (NDA): 212593

NDA 212593 describes VASOPRESSIN, which is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Dr Reddys, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Baxter Hlthcare Corp, and Long Grove Pharms, and is included in eleven NDAs. It is available from nine suppliers. Additional details are available on the VASOPRESSIN profile page.

The generic ingredient in VASOPRESSIN is vasopressin. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.

Summary for 212593

Tradename:	VASOPRESSIN
Applicant:	Am Regent
Ingredient:	vasopressin
Patents:	0

Pharmacology for NDA: 212593

Physiological Effect

Decreased Diuresis Vasoconstriction

Suppliers and Packaging for NDA: 212593

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VASOPRESSIN	vasopressin	SOLUTION;INTRAVENOUS	212593	NDA	American Regent, Inc.	0517-1020	0517-1020-25	25 VIAL, SINGLE-DOSE in 1 CARTON (0517-1020-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-1020-01)
VASOPRESSIN	vasopressin	SOLUTION;INTRAVENOUS	212593	NDA	American Regent, Inc.	0517-1030	0517-1030-01	1 VIAL, MULTI-DOSE in 1 CARTON (0517-1030-01) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	20UNITS/ML (20UNITS/ML)
Approval Date:	Aug 3, 2020	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200UNITS/10ML (20UNITS/ML)
Approval Date:	Jun 9, 2023	TE:		RLD:	Yes

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