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Generated: April 25, 2019

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Details for New Drug Application (NDA): 202402

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NDA 202402 describes IBUPROFEN LYSINE, which is a drug marketed by X-gen Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the IBUPROFEN LYSINE profile page.

The generic ingredient in IBUPROFEN LYSINE is ibuprofen lysine. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.
Summary for 202402
Tradename:IBUPROFEN LYSINE
Applicant:X-gen Pharms Inc
Ingredient:ibuprofen lysine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202402
Suppliers and Packaging for NDA: 202402
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN LYSINE ibuprofen lysine INJECTABLE;INTRAVENOUS 202402 ANDA X-GEN Pharmaceuticals, Inc. 39822-1030 39822-1030-2 3 VIAL in 1 CARTON (39822-1030-2) > 2 mL in 1 VIAL (39822-1030-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date:Mar 30, 2016TE:APRLD:No

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