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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019892
Company: RHODES PHARMS

Medication Guide

REMS

Products on NDA 019892

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	AB	Yes	Yes
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	AB	Yes	No
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019892

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-41	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-37	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-35	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-34	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-33	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-29	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
01/26/2015	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
07/05/2013	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
12/18/2012	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
01/24/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/09/2007	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019892s015ltr.pdf
06/12/2006	SUPPL-9	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
04/12/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/22/2001	SUPPL-4	Labeling		Label is not available on this site.
02/24/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/10/2003	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19891slr002,19892slr002ltr.pdf
03/31/1995	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019892

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019891s031,019892s041lbl.pdf
03/04/2021	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf
10/07/2019	SUPPL-35	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
10/07/2019	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
09/18/2018	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
09/18/2018	SUPPL-33	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
12/16/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
12/16/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
11/09/2007	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf
06/12/2006	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf

Therapeutic Equivalents for NDA 019892

DILAUDID

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	Yes	AB	019892	RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AB	210506	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AB	205814	AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	8MG	TABLET;ORAL	Prescription	No	AB	076855	SPECGX LLC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	Yes	AB	019892	RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	210506	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	205814	AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	078439	LANNETT
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	076855	SPECGX LLC

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	Yes	AB	019892	RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	210506	ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	205814	AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	078439	LANNETT
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	076855	SPECGX LLC

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