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Last Updated: January 17, 2021

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Details for New Drug Application (NDA): 019891

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NDA 019891 describes DILAUDID, which is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. It is available from three suppliers. There are three patents protecting this drug and four Paragraph IV challenges. Additional details are available on the DILAUDID profile page.

The generic ingredient in DILAUDID is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 019891
Tradename:DILAUDID
Applicant:Rhodes Pharms
Ingredient:hydromorphone hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 019891
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 019891
Suppliers and Packaging for NDA: 019891
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILAUDID hydromorphone hydrochloride SOLUTION;ORAL 019891 NDA AUTHORIZED GENERIC Rhodes Pharmaceuticals L.P. 42858-304 42858-304-16 473 mL in 1 BOTTLE, PLASTIC (42858-304-16)
DILAUDID hydromorphone hydrochloride SOLUTION;ORAL 019891 NDA Rhodes Pharmaceuticals L.P. 42858-416 42858-416-16 473 mL in 1 BOTTLE, PLASTIC (42858-416-16)
Paragraph IV (Patent) Challenges for 019891
Tradename Dosage Ingredient NDA Submissiondate
DILAUDID SOLUTION;ORAL hydromorphone hydrochloride 019891 2011-02-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Dec 7, 1992TE:AARLD:Yes
Patent:  Start TrialPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?YDelist Request?

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