Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078228
Company: RISING

Products on ANDA 078228

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/2010	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
04/24/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/20/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/20/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/04/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078228

HYDROMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078591	HOSPIRA INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078228	RISING
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078261	RISING