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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 213206


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NDA 213206 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 213206
Tradename:VASOPRESSIN
Applicant:Fresenius Kabi Usa
Ingredient:vasopressin
Patents:0
Pharmacology for NDA: 213206
Physiological EffectDecreased Diuresis
Vasoconstriction
Suppliers and Packaging for NDA: 213206
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VASOPRESSIN vasopressin SOLUTION;INTRAVENOUS 213206 ANDA Fresenius Kabi USA, LLC 63323-930 63323-930-01 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-930-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-930-00)
VASOPRESSIN vasopressin SOLUTION;INTRAVENOUS 213206 ANDA Fresenius Kabi USA, LLC 65219-039 65219-039-01 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-039-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-039-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20UNITS/ML (20UNITS/ML)
Approval Date:May 26, 2023TE:APRLD:No

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