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

Tradename:	DILAUDID
Applicant:	Rhodes Pharms
Ingredient:	hydromorphone hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019891

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 019891

Analgesics, Opioid
Narcotics

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:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Dec 7, 1992	TE:	AA	RLD:	Yes

Expired US Patents for NDA 019891

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	SOLUTION;ORAL	019891-001	Dec 7, 1992	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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