Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076855
Company: SPECGX LLC

• REMS

Products on ANDA 076855

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	AB	No	No
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 076855

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2025	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-22	REMS-Modified		Label is not available on this site.
03/13/2025	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/09/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/09/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-13	REMS - PROPOSAL - D-N-A		Label is not available on this site.
03/09/2020	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/06/2008	SUPPL-5	Labeling		Label is not available on this site.
11/09/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076855

HYDROMORPHONE HYDROCHLORIDE

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	Yes	AB	019892	RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AB	210506	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AB	205814	AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AB	076855	SPECGX LLC

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