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 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 019892

Tradename:	DILAUDID
Applicant:	Rhodes Pharms
Ingredient:	hydromorphone hydrochloride
Patents:	0

Pharmacology for NDA: 019892

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 019892

Analgesics, Opioid
Narcotics

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	42858-122-01	100 TABLET in 1 BOTTLE, PLASTIC (42858-122-01)
DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892	NDA	Rhodes Pharmaceuticals L.P.	42858-234	42858-234-01	100 TABLET in 1 BOTTLE, PLASTIC (42858-234-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Dec 7, 1992	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Nov 9, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Nov 9, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019892

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-003	Nov 9, 2007	⤷ Sign Up	⤷ Sign Up
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-001	Dec 7, 1992	⤷ Sign Up	⤷ Sign Up
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-002	Nov 9, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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