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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019892

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NDA 019892 describes DILAUDID, which is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. It is available from five 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. Twenty-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 019892
Tradename:DILAUDID
Applicant:Rhodes Pharms
Ingredient:hydromorphone hydrochloride
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 019892
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 019892
Suppliers and Packaging for NDA: 019892
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892 NDA Rhodes Pharmaceuticals L.P. 42858-122 N 42858-122-01
DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892 NDA Rhodes Pharmaceuticals L.P. 42858-122 N 42858-122-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 7, 1992TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Nov 9, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 9, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?YDelist Request?

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