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Last Updated: June 7, 2023

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 four suppliers. There are two 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
Applicant:Rhodes Pharms
Ingredient:hydromorphone hydrochloride
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Dec 7, 1992TE:AARLD:Yes

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Serving leading biopharmaceutical companies globally:

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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 verification 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.