Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074653
Company: HIKMA

• REMS

Products on ANDA 074653

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 074653

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74653ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-17	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/10/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/10/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-9	REMS - PROPOSAL - D-N-A		Label is not available on this site.
10/18/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/11/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074653

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