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Serving leading biopharmaceutical companies globally:

Healthtrust
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Cantor Fitzgerald
Fuji
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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204278

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NDA 204278 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, Nesher Pharms, and Specgx Llc, and is included in twenty 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 204278
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Paddock Llc
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 204278
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 204278
Suppliers and Packaging for NDA: 204278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 ANDA Paddock Laboratories, LLC 0574-0293 N 0574-0293-01
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 ANDA Paddock Laboratories, LLC 0574-0294 N 0574-0294-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:Apr 6, 2015TE:ABRLD:No

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