Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018565
Company: HIKMA

Products on NDA 18565

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

Labels for NDA 018565

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s027,s031lbl.pdf
12/15/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s028s030lbl.pdf
12/15/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s028s030lbl.pdf
12/15/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565s027,s031lbl.pdf
11/08/2023	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018565Orig1s029lbl.pdf
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