Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 018565
Company: HIKMA

Products on NDA 018565

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018565

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/1984	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		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-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018565s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018565Orig1s024ltr.pdf
12/16/2016	SUPPL-22	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Label (PDF) Letter (PDF) Letter (PDF)	DURAMORPH & INFUMORPH have separate letters and labels	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Duramorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Infumorph.pdf
06/06/2016	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
10/01/2010	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)	Label for DURAMORPH	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018565s020ltr.pdf
06/06/2005	SUPPL-14	Labeling	Label (PDF) Letter (PDF)	Label for DURAMORPH	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018565s014ltr.pdf
05/27/2004	SUPPL-12	Labeling	Label (PDF) Letter (PDF)	Label for INFUMORPH	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18565slr012ltr.pdf
06/26/2003	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18565slr010ltr.pdf
12/07/2001	SUPPL-9	Labeling		Label is not available on this site.
06/14/1999	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/1998	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/12/1997	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/28/1994	SUPPL-5	Labeling		Label is not available on this site.
05/03/1989	SUPPL-4	Labeling		Label is not available on this site.
07/19/1991	SUPPL-3	Labeling		Label is not available on this site.
07/19/1991	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/22/1985	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018565

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

Therapeutic Equivalents for NDA 018565

DURAMORPH PF

INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DURAMORPH PF	MORPHINE SULFATE	0.5MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018565	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	0.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	071849	HOSPIRA
MORPHINE SULFATE	MORPHINE SULFATE	0.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	073509	HOSPIRA

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DURAMORPH PF	MORPHINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018565	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	073510	HOSPIRA

INFUMORPH

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	No	AP	211452	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	10MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	202515	HOSPIRA INC

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INFUMORPH	MORPHINE SULFATE	25MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018565	HIKMA
MITIGO	MORPHINE SULFATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204393	PIRAMAL CRITICAL