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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 are three patents 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-three 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 NDA: 021903

Tradename:
NEOPROFEN
Applicant:
Recordati Rare
Ingredient:
ibuprofen lysine
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 021903

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

Summary 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:8,415,337Patent Expiration:Mar 2, 2032Product Flag?YSubstance Flag?YDelist Request?
Patent:6,342,530Patent Expiration:Nov 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
Patent:6,344,479Patent Expiration:Mar 20, 2021Product Flag?YSubstance Flag?YDelist Request?Y
Patented Use:CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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