Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200403
Company: HOSPIRA INC
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
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/2011/200403s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000TAltr.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
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-Medication Guide, Labeling-Package Insert, Labeling-Package Insert 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.

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

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 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

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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