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Generated: February 25, 2018

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 two suppliers. There is one patent 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. Twenty-six 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:1
Therapeutic Class:Analgesics
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 Purdue Pharma LP 59011-442 N 59011-442-10
DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034 NDA Purdue Pharma LP 59011-442 N 59011-442-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jan 11, 1984TE:APRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength250MG/VIAL
Approval Date:Aug 4, 1994TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Apr 30, 2009TE:APRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?YDelist Request?

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