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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076855

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NDA 076855 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Hospira Inc, Nesher Pharms, Aurolife Pharma Llc, Watson Labs, Elite Labs, Akorn, Osmotica, Lannett, Barr, Actavis Labs Fl Inc, West-ward Pharms Int, Mallinckrodt, Paddock Llc, and Hospira, and is included in eighteen NDAs. It is available from nineteen suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE 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: 076855

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076855

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 076855

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
 TABLET;ORAL 076855 ANDA Mallinckrodt, Inc. 0406-3243 0406-3243-01 100 TABLET in 1 BOTTLE (0406-3243-01)
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
 TABLET;ORAL 076855 ANDA Mallinckrodt, Inc. 0406-3244 0406-3244-01 100 TABLET in 1 BOTTLE (0406-3244-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 23, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 19, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 19, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Cipla
Fuji
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