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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021903


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NDA 021903 describes NEOPROFEN, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the NEOPROFEN profile page.

The generic ingredient in NEOPROFEN 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 021903
Tradename:NEOPROFEN
Applicant:Recordati Rare
Ingredient:ibuprofen lysine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021903
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 021903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903 NDA Recordati Rare Diseases Inc. 55292-122 55292-122-52 3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL
NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-490 66993-490-36 3 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date:Apr 13, 2006TE:APRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 2, 2032Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 021903

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 ⤷  Try a Trial ⤷  Try a Trial
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903-001 Apr 13, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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