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Generated: July 28, 2017

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 Hospira Inc, Nesher Pharms, Aurolife Pharma Llc, Watson Labs, Elite Labs, Akorn, Osmotica, Lannett, Barr, Actavis Labs Fl Inc, West-ward Pharms Int, Mallinckrodt, Paddock Llc, and Hospira, and is included in eighteen 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-seven suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for NDA: 202144

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

Pharmacology for NDA: 202144

Mechanism of ActionFull Opioid Agonists

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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:May 12, 2014TE: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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