Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210176
Company: ASCENT PHARMS INC

• REMS

Products on ANDA 210176

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210176

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2018	SUPPL-2	REMS - PROPOSAL - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 210176

HYDROMORPHONE HYDROCHLORIDE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	019891	RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210176	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	074653	HIKMA