Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 019034
Company: FRESENIUS KABI USA

Products on NDA 019034

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No
DILAUDID-HP	HYDROMORPHONE HYDROCHLORIDE	250MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/1984	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-48	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019034s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019034Orig1s048ltr.pdf
12/15/2023	SUPPL-46	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019034s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019034Orig1s046ltr.pdf
01/16/2020	SUPPL-37		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019034s037lbl.pdf
10/07/2019	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019034Orig1s035ltr.pdf
01/26/2018	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
02/10/2017	SUPPL-29	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019034s029lbl.pdf
12/16/2016	SUPPL-27	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019034Orig1s027ltr.pdf
12/16/2016	SUPPL-25	Manufacturing (CMC)-Manufacturing Process	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019034Orig1s025ltr.pdf
06/30/2011	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019034s021ltr.pdf
04/30/2009	SUPPL-18	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019034s018ltr.pdf
06/12/2006	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019034s012LTR.pdf
11/09/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/2001	SUPPL-8	Labeling		Label is not available on this site.
08/08/1994	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
08/04/1994	SUPPL-6	Labeling		Label is not available on this site.
10/16/1991	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/16/1991	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/29/1984	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019034

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
12/22/2025	SUPPL-48	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019034s048lbl.pdf
12/15/2023	SUPPL-46	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019034s046lbl.pdf
01/16/2020	SUPPL-37	Manufacturing (CMC)	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019034s037lbl.pdf
10/07/2019	SUPPL-35	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019034s035lbl.pdf
02/10/2017	SUPPL-29	Manufacturing (CMC)-Packaging	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019034s029lbl.pdf
12/16/2016	SUPPL-27	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf
12/16/2016	SUPPL-27	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf
06/30/2011	SUPPL-21	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf
04/30/2009	SUPPL-18	Efficacy-New Dosing Regimen	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf
06/12/2006	SUPPL-12	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf

Therapeutic Equivalents for NDA 019034

DILAUDID

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019034	FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216899	HIKMA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	200403	HOSPIRA INC

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019034	FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	202159	HIKMA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216899	HIKMA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	200403	HOSPIRA INC

INJECTABLE;INJECTION; 4MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019034	FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	200403	HOSPIRA INC

INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019034	FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216899	HIKMA

INJECTABLE;INJECTION; 0.5MG/0.5ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILAUDID	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019034	FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AP	216899	HIKMA

DILAUDID-HP

There are no Therapeutic Equivalents.