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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202515
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 2MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE;INJECTION Prescription AP Yes No
MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE;INJECTION Prescription AP Yes No
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription AP Yes No
MORPHINE SULFATE MORPHINE SULFATE 15MG/ML INJECTABLE;INJECTION Discontinued None Yes No
MORPHINE SULFATE MORPHINE SULFATE 50MG/ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/14/2011 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202515s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515_morphine_sulfate_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2022 SUPPL-33 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202515Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202515Orig1s033ltr.pdf
04/29/2021 SUPPL-25 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202515s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202515Orig1s025ltr.pdf
10/07/2019 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202515s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202515Orig1s017ltr.pdf
08/17/2020 SUPPL-7 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202515Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202515Orig1s007ltr.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202515s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202515Orig1s006ltr.pdf
08/14/2013 SUPPL-3 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
04/28/2022 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202515Orig1s033lbl.pdf
04/28/2022 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202515Orig1s033lbl.pdf
04/29/2021 SUPPL-25 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202515s025lbl.pdf
08/17/2020 SUPPL-7 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202515Orig1s007lbl.pdf
10/07/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202515s017lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202515s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202515s006lbl.pdf
11/14/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202515Orig1s000Lbl.pdf

MORPHINE SULFATE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE;INJECTION Prescription No AP 205758 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE;INJECTION Prescription Yes AP 202515 HOSPIRA INC

INJECTABLE;INJECTION; 8MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE;INJECTION Prescription No AP 205758 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE;INJECTION Prescription Yes AP 202515 HOSPIRA INC

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INFUMORPH MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 HIKMA
MITIGO MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 204393 PIRAMAL CRITICAL
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 205758 HIKMA
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 202515 HOSPIRA INC
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