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Covington
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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019034

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NDA 019034 describes DILAUDID-HP, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. 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 fourteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for NDA: 019034

Tradename:
2
Applicant:
1
Ingredient:
1
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 59011-442 59011-442-10 10 AMPULE in 1 CARTON (59011-442-10) > 2 mL in 1 AMPULE
DILAUDID
hydromorphone hydrochloride
INJECTABLE;INJECTION 019034 NDA Purdue Pharma LP 59011-442 59011-442-25 25 AMPULE in 1 CARTON (59011-442-25) > 2 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:► SubscribePatent 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:► SubscribePatent 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:► SubscribePatent Expiration:Nov 9, 2020Product Flag?YSubstance Flag?YDelist Request?


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Moodys
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