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Generated: September 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202144

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NDA 202144 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, Eurohlth Intl Sarl, 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 Co Inc, Nesher Pharms, and Specgx Llc, and is included in twenty 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-three suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 202144
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Actavis Labs Fl Inc
Ingredient:hydromorphone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202144
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 202144
Suppliers and Packaging for NDA: 202144
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202144 ANDA Actavis Pharma, Inc. 0591-3629 0591-3629-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3629-01)
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202144 ANDA Actavis Pharma, Inc. 0591-3629 0591-3629-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3629-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:May 12, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:May 12, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:May 12, 2014TE:ABRLD:No

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