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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018565
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DURAMORPH PF MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DURAMORPH PF MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
INFUMORPH MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
INFUMORPH MORPHINE SULFATE 25MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018565s024lbl.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf
10/01/2010 SUPPL-20 Labeling-Package Insert Label (PDF) Label for DURAMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf
06/06/2005 SUPPL-14 Labeling Label (PDF) Label for DURAMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf
05/27/2004 SUPPL-12 Labeling Label (PDF) Label for INFUMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf
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