An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019891
Company: RHODES PHARMS

Medication Guide

REMS

Products on NDA 019891

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019891

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/1992	ORIG-1	Approval	Type 3 - New Dosage Form	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-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019891s031,019892s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019891Orig1s031; 019892Orig1s041ltr.pdf
03/04/2021	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019891Orig1s029,019892Orig1s037ltr.pdf
10/07/2019	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019891Orig1s028, 019892Orig1s035ltr.pdf
09/18/2018	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf
09/18/2018	SUPPL-26	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf
12/16/2016	SUPPL-24	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019891Orig1s024,019892Orig1s029ltr.pdf
02/05/2016	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
02/12/2016	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/12/2016	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/09/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/16/2015	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/14/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/12/2006	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019891s008, 019892s009LTR.pdf
08/22/2001	SUPPL-4	Labeling		Label is not available on this site.
11/24/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/10/2003	SUPPL-2	Labeling		Label is not available on this site.
03/31/1995	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019891

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019891s031,019892s041lbl.pdf
03/04/2021	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf
10/07/2019	SUPPL-28	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
10/07/2019	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
09/18/2018	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
09/18/2018	SUPPL-26	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
12/16/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
12/16/2016	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
06/12/2006	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf

Therapeutic Equivalents for NDA 019891

DILAUDID

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

Top