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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 216379


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NDA 216379 describes TIROFIBAN HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland Pharma Ltd, and Nexus, and is included in three NDAs. It is available from three suppliers. Additional details are available on the TIROFIBAN HYDROCHLORIDE profile page.

The generic ingredient in TIROFIBAN HYDROCHLORIDE is tirofiban hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
Summary for 216379
Tradename:TIROFIBAN HYDROCHLORIDE
Applicant:Eugia Pharma
Ingredient:tirofiban hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 216379
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 216379
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 216379 ANDA Eugia US LLC 55150-429 55150-429-01 1 POUCH in 1 CARTON (55150-429-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 216379 ANDA Eugia US LLC 55150-430 55150-430-01 1 POUCH in 1 CARTON (55150-430-01) / 1 BAG in 1 POUCH / 250 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Approval Date:May 1, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Approval Date:May 1, 2023TE:APRLD:No

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