Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212133
Company: ASCENT PHARMS INC

• REMS

Products on ANDA 212133

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2020	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
12/15/2023	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 212133

HYDROMORPHONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212133	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205629	OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204278	PADAGIS US

TABLET, EXTENDED RELEASE;ORAL; 12MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212133	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205629	OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	12MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204278	PADAGIS US

TABLET, EXTENDED RELEASE;ORAL; 16MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212133	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205629	OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	16MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204278	PADAGIS US

TABLET, EXTENDED RELEASE;ORAL; 32MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212133	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205629	OSMOTICA PHARM US
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	32MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204278	PADAGIS US