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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019034

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NDA 019034 describes DILAUDID-HP, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DILAUDID-HP profile page.

The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 019034
Tradename:DILAUDID-HP
Applicant:Fresenius Kabi Usa
Ingredient:hydromorphone hydrochloride
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 019034
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 019034
Suppliers and Packaging for NDA: 019034
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034 NDA Fresenius Kabi USA, LLC 63323-851 63323-851-10 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-10) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-851-03)
DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034 NDA Fresenius Kabi USA, LLC 63323-851 63323-851-15 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-15) > 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07)
Paragraph IV (Patent) Challenges for 019034
Tradename Dosage Ingredient NDA Submissiondate
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jan 11, 1984TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 12, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 23, 2032Product Flag?YSubstance Flag?Delist Request?

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