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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076855


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NDA 076855 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Genus, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Nesher Pharms, Nostrum Labs Inc, and Specgx Llc, and is included in twenty-three NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 076855
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:hydromorphone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076855
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076855
Suppliers and Packaging for NDA: 076855
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855 ANDA SpecGx LLC 0406-3243 0406-3243-01 100 TABLET in 1 BOTTLE (0406-3243-01)
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855 ANDA SpecGx LLC 0406-3244 0406-3244-01 100 TABLET in 1 BOTTLE (0406-3244-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 23, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 19, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 19, 2007TE:ABRLD:No

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