Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
McKesson
AstraZeneca
Moodys
Mallinckrodt

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204278

See Plans and Pricing

« Back to Dashboard

NDA 204278 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 sixteen 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. Eighteen 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
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 0574-0293-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0293-01)
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 ANDA Paddock Laboratories, LLC 0574-0294 0574-0294-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
McKinsey
Moodys
Boehringer Ingelheim
Johnson and Johnson

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.