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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022195
Company: HIKMA

Medication Guide

REMS

Summary Review

Products on NDA 022195

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	No
MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	No
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2008	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/label/2008/022195,022207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000, 022207s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195_022207_morphine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022195s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022195Orig1s021ltr.pdf
07/22/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s020ltr.pdf
03/04/2021	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s019ltr.pdf
10/07/2019	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022195s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022195Orig1s018ltr.pdf
09/18/2018	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022195Orig1s014s016ltr.pdf
09/18/2018	SUPPL-14	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022195Orig1s014s016ltr.pdf
12/16/2016	SUPPL-11	Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022195Orig1s011ltr.pdf
06/02/2021	SUPPL-10	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s010, 022207Orig1s005ltr.pdf
01/09/2014	SUPPL-9	Labeling-Medication Guide	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022195Orig1s009ltr.pdf
04/18/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/21/2015	SUPPL-7	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022195s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022195Orig1s007ltr.pdf
01/23/2012	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022195s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022195s006ltr.pdf
10/18/2011	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022195s005ltr.pdf
06/10/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/25/2010	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022195s002ltr.pdf

Labels for NDA 022195

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022195s021lbl.pdf
07/22/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s020lbl.pdf
06/02/2021	SUPPL-10	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s010lbl.pdf
03/04/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf
10/07/2019	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022195s018lbl.pdf
10/07/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022195s018lbl.pdf
09/18/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf
09/18/2018	SUPPL-14	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf
12/16/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf
12/16/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf
12/16/2016	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf
04/21/2015	SUPPL-7	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022195s007lbl.pdf
01/23/2012	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022195s006lbl.pdf
01/25/2010	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf
03/17/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf

Therapeutic Equivalents for NDA 022195

MORPHINE SULFATE

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	022195	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206308	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	203518	TRIS PHARMA INC
MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211454	WINDER LABS LLC

SOLUTION;ORAL; 20MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	022195	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206420	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211454	WINDER LABS LLC

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	022195	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	201574	PADAGIS US
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206308	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	202348	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	203518	TRIS PHARMA INC
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211454	WINDER LABS LLC

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