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Details for New Drug Application (NDA): 074597

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NDA 074597 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, Roxane, Mallinckrodt, Paddock Llc, and Hospira, and is included in eighteen NDAs. It is available from twenty suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are thirteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for NDA: 074597

Tradename:
HYDROMORPHONE HYDROCHLORIDE
Applicant:
Roxane
Ingredient:
hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 074597

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 074597

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL 074597 ANDA West-Ward Pharmaceuticals Corp. 0054-0264 0054-0264-24 4 CONTAINER in 1 CARTON (0054-0264-24) > 25 TABLET in 1 CONTAINER
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL 074597 ANDA West-Ward Pharmaceuticals Corp. 0054-0264 0054-0264-25 100 TABLET in 1 BOTTLE (0054-0264-25)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jul 29, 1998TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 29, 2009TE:ABRLD:No


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