An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078439
Company: LANNETT

Products on ANDA 078439

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	AB	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078439

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2009	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078439

HYDROMORPHONE HYDROCHLORIDE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	Yes	AB	019892	RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	210506	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	205814	AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	078439	LANNETT
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	076855	SPECGX LLC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	Yes	AB	019892	RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	210506	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	205814	AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	078439	LANNETT
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	076855	SPECGX LLC

Top