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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200403
Company: HOSPIRA INC

Summary Review

Products on NDA 200403

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200403

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2011	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200403s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403_hydromorphone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-48	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200403s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200403Orig1s048ltr.pdf
10/07/2019	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200403s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200403Orig1s018ltr.pdf
11/21/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/16/2016	SUPPL-6	Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200403s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200403Orig1s006ltr.pdf
09/03/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/16/2015	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200403s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200403Orig1s004ltr.pdf
08/18/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/11/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 200403

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200403s048lbl.pdf
10/07/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200403s018lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200403s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200403s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200403s006lbl.pdf
07/16/2015	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200403s004lbl.pdf
12/01/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200403s000lbl.pdf

Therapeutic Equivalents for NDA 200403

HYDROMORPHONE HYDROCHLORIDE

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
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	200403	HOSPIRA INC

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