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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022207
Company: HIKMA

Medication Guide

REMS

Summary Review

Products on NDA 022207

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	AB	Yes	No
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022207

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-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022207s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022207Orig1s011ltr.pdf
03/04/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022207Orig1s010ltr.pdf
10/07/2019	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022207Orig1s009ltr.pdf
09/18/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022207Orig1s007s008ltr.pdf
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022207Orig1s007s008ltr.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022207Orig1s006ltr.pdf
06/02/2021	SUPPL-5	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022195Orig1s010,%20022207Orig1s005ltr.pdf
01/23/2012	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022207s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022207s004ltr.pdf
04/15/2010	SUPPL-2	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022207s002ltr.pdf

Labels for NDA 022207

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022207s011lbl.pdf
06/02/2021	SUPPL-5	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s005lbl.pdf
03/04/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf
10/07/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf
10/07/2019	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf
09/18/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf
01/23/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022207s004lbl.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 022207

MORPHINE SULFATE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	212451	ALKEM LABS LTD
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	Yes	AB	022207	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	215194	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	No	AB	210610	UPSHER SMITH LABS

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	212451	ALKEM LABS LTD
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	Yes	AB	022207	HIKMA
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	215194	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	No	AB	210610	UPSHER SMITH LABS

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