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Details for New Drug Application (NDA): 019034

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NDA 019034 describes DILAUDID-HP, which is a drug marketed by Purdue Pharm Prods and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DILAUDID-HP profile page.

The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are thirteen 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 NDA: 019034

Tradename:
DILAUDID
Applicant:
Purdue Pharm Prods
Ingredient:
hydromorphone hydrochloride
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 019034

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 019034

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILAUDID
hydromorphone hydrochloride
INJECTABLE;INJECTION 019034 NDA Purdue Pharma LP 59011-441 59011-441-10 10 AMPULE in 1 CARTON (59011-441-10) > 1 mL in 1 AMPULE
DILAUDID-HP
hydromorphone hydrochloride
INJECTABLE;INJECTION 019034 NDA Purdue Pharma LP 59011-441 59011-441-10 10 AMPULE in 1 CARTON (59011-441-10) > 1 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jan 11, 1984TE:APRLD:Yes
Patent:6,589,960Patent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength250MG/VIAL
Approval Date:Aug 4, 1994TE:RLD:No
Patent:6,589,960Patent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Apr 30, 2009TE:APRLD:Yes
Patent:6,589,960Patent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?YDelist Request?


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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 verifification 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.

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