Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019034
Company: FRESENIUS KABI USA
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 Discontinued None Yes No
DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Discontinued None Yes No
DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE 250MG/VIAL INJECTABLE;INJECTION Discontinued None No No
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 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 EUROHLTH INTL SARL
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 200403 HOSPIRA INC

DILAUDID-HP

There are no Therapeutic Equivalents.

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