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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074597

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NDA 074597 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, Hospira, Hospira Inc, Watson Labs, Ascent Pharms Inc, West-ward Pharms Int, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett, Mallinckrodt, and Nesher Pharms, and is included in nineteen 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 fourteen 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 074597

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 074597

Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for 074597

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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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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