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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076723

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NDA 076723 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: 076723

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076723

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 076723

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydromorphone hydrochloride
TABLET;ORAL 076723 ANDA TAGI Pharma, Inc. 51224-102 51224-102-50 100 TABLET in 1 BOTTLE (51224-102-50)
hydromorphone hydrochloride
TABLET;ORAL 076723 ANDA Precision Dose Inc. 68094-852 68094-852-61 100 TABLET in 1 CARTON (68094-852-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Oct 18, 2005TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

US Army
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Chinese Patent Office
Queensland Health
Farmers Insurance

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